Reduction Instrument for Spondylolisthesis, standard, for Matrix 5.5 의 안전성 경고

Safety alert

2013-06-18

2013-06-18

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130618.html

Medical device safety alert: synthes reduction instrument for spondylolisthesis, standard, for matrix 5.5 medical device manufacturer, synthes issued a medical device safety alert concerning reduction instrument for spondylolisthesis, standard, for matrix 5.5 (part number: 03.632.008; lot numbers: all). synthes received complaints that during spine surgery using the reduction instrument for spondylolisthesis, standard, for matrix 5.5 (03.632.008), the reduction insert broke and pieces broke off. once the reduction insert breaks, the instrument does not function as required. synthes explained that in a hypothetical worst case scenario, if the insert breaks and fragment(s) are retained, they may not be retrieved. additional operative time may be required to attempt retrieval and x-ray may not be effective to confirm that all fragments have been retrieved because the fragments are radiolucent. if fragments are retained there is a potential for an unfavorable response to the foreign material (chemical, biological or physical) within the body (including implant-related metal debris, wear particles, non-biocompatible materials) to occur which may trigger a localised reaction. the patient may be symptomatic requiring treatment and non-surgical treatment will not be effective as the disease progresses requiring revision surgery or reoperation. if treated on time, no permanent impairment is expected. according to the manufacturer, misassembly of the instrument in the operating room is a probable root cause of this safety issue. synthes has decided to remove the product from the market. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 jun 2013.