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.
데이터 추가 비고
Patient specific manual orthopedic stereotaxic system - Product Code OSF
원인
Potential inaccuracies in the alignment of the guides. surgery was inaccurately planned because the patient image data was incorrectly processed.
조치
On September 16, 2015 Materialise NV identified four cases where not all available image sets were used to design the case. On September 18, 2015, prior to the surgery dates Materialise informed (phone call) the Signature
Services Manager of Zimmer Biomet that inaccuracies in the alignment of the knee might be observed with the use of the guides due to this issue. Biomet was asked to segregate the packages for these four cases and to return them to the Materialise US office. On September 23, 2015 this was
followed up by e-mail notification letter with response forms.
Biomet was requested to contact Materialise customer service to return these four cases and arrange a replacement set of patient specific surgical guides Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. E-mail : ortho-quality@materialise. be
Customer Service
Materialise USA LLC
44650 Helm Court
Plymouth, Michigan 48170
734-259-7033
Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.