FDA Adverse Event
Injury
Summary report: N
SCREW, FIXATION, BONE
MDR report key: 2981366
·
Received February 27, 2013
Report
- Report Number
- 2520274-2013-01200
- Event Type
- Injury
- Date Received
- February 27, 2013
- Report Date
- January 29, 2013
- Manufacturer
- SYNTHES, USA
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. A MANUFACTURING AND/OR PRODUCT INVESTIGATION COULD NOT BE PERFORMED AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE IMPLANT BEAK IS OUT. IT WAS ALSO NOTED THE IMPLANT'S PLATE AND SCREW WERE LOOSENING. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85052 | SCREW, FIXATION, BONE | HWC | SYNTHES, USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |