FDA Adverse Event
Malfunction
Summary report: N
LOCKING SCREW NUMELOCK II 6.5X45MM
MDR report key: 2566460
·
Received May 2, 2012
Report
- Report Number
- 8031020-2012-00114
- Event Type
- Malfunction
- Date Received
- May 2, 2012
- Date of Event
- April 2, 2012
- Report Date
- April 19, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- KWH
- PMA / PMN Number
- K041709
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. SAME PT EVENT AS MDR 8031020-2012-00115.
Description of Event or Problem · 1
MRS (B)(6), PHARMACIST AT THE HOSPITAL, ALLEGED THE FOLLOWING EVENT: "DURING THE EXTRACTION OF A FEMORAL PLATE, 2 SCREWS FRACTURED. THE DEVICES WERE IMPLANTED FOR A LITTLE MORE THAN 1 YEAR. THE SCREWS COULD NOT BE RETRIEVED AND WERE LEFT IN THE EPIPHYSIS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOCKING SCREW NUMELOCK II 6.5X45MM | IMPLANT | KWH | STRYKER OSTEOSYNTHESIS SELZACH | NA | W00553 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other |