U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Physician instructions revised due to product breakage: during the implantation of the x-stop ipd device, the product has the potential to cause damage to and/or breakage of the x-stop ipd device's universal wing assembly. this includes the potential for breakage of the wing screw.
조치
On January 30, Kyphon sent a letter to all consignees, and a teleconference was held with sales management informing them of the recall and the need to contact consignees. The product labeling including the Physician Training and Physician's Guide have been updated to reflect the potential risk of breakage.
Worldwide distribution: USA, UK, Netherlands, Canada, Australia, Denmark, Germany, Greece, Hong Kong, Israel, Italy, Philippines, Portugal, Singapore, South Africa, Spain Switzerland, Turkey and UAE.
제품 설명
X-STOP Interspinous Process Decompression (lPD) System, || (With Physician's Guide, P/N 16000789-01 (Ti device), P/N 16001013-01 (PEEK device); || Catalog numbers for X-STOP Titanium Implant: 1-2206 US 6MM X-STOP, 1-2208 US 8MM X-STOP, 1-2210 US 10MM X-STOP, 1-2212 US 12MM X-STOP, 1-2214 US 14MM X-STOP. || Catalog numbers include for X-STOP PEEK Implant: 1-3206 US 6mm X STOPpk, 1-3208 US 8mm X STOPpk, 1-3210 US 10mm X STOPpk, 1-3212 US 12mm X STOPpk, 1-3214 US 14mm X STOPpk, 1-3216 US 16mm X STOPpk. || Product is manufactured and distributed by Medtronic Spine LLC (formerly Kyphon Inc.); || Spinal implants.
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.