FDA Adverse Event
Malfunction
Summary report: N
CMF CUSTOMIZED IMPLANT KIT LARGE
MDR report key: 2717206
·
Received August 15, 2012
Report
- Report Number
- 2249697-2012-01280
- Event Type
- Malfunction
- Date Received
- August 15, 2012
- Date of Event
- August 6, 2012
- Report Date
- August 6, 2012
- Manufacturer
- IT WAS REPORTED THAT, THE CASE DID NOT FIT WELL MISSING 10-15MM INSIDE TEMPORAL
- Product Code
- GWO
- PMA / PMN Number
- K103010
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, THE CASE DID NOT FIT WELL MISSING 10-15MM INSIDE TEMPORAL REGION. THE SURGEON AUGMENTED WITH CEMENT AND THE CASE WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CMF CUSTOMIZED IMPLANT KIT LARGE | IMPLANT | GWO | IT WAS REPORTED THAT, THE CASE DID NOT FIT WELL MISSING 10-15MM INSIDE TEMPORAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |