FDA Adverse Event
Injury
Summary report: N
MULTILOC SCREW Ø4.5 L40 TAN
MDR report key: 3100120
·
Received May 8, 2013
Report
- Report Number
- 2520274-2013-02440
- Event Type
- Injury
- Date Received
- May 8, 2013
- Report Date
- April 11, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- HSB
- PMA / PMN Number
- K103002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADDITIONAL INFORMATION. RECEIVED FROM SYNTHES (B)(4).
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.
Additional Manufacturer Narrative · 1
DEVICE USED FOR TREATMENT, NOT DIAGNOSIS.
Description of Event or Problem · 1
DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A SURGERY ON AN UNKNOWN DATE, IT WAS NOTICED THAT TWO OF THE MULTILOCK SCREWS BACKED OUT FROM THE HUMERAL NAIL. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 200343 | MULTILOC SCREW Ø4.5 L40 TAN | HSB | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |