CMF CUSTOMIZED IMPLANT KIT LARGE
Received Nov 22, 2011 · Event occurred Nov 1, 2011
Report 2249697-2011-01654 · MDR key 2397404
Device
Generic name
Implant
Manufacturer
Stryker Orthopaedics MahwahModel number
NACatalog number
5444-0-300
Lot number
UNK
Product problems
- Crack
Patient
UNK
- No Information
Narrative
Additional Manufacturer Narrative
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
THE SURGEON WAS PUTTING THE SECOND OR THIRD SCREW INTO THE IMPLANT AND AS THE SCREW WAS TIGHTENING THE IMPLANT CRACKED. THEY ENDED UP IMPLANTING THE PRODUCT AND THE SCREW CONTINUED TO HOLD.
Remedial action
- Other