FDA Adverse Event
Malfunction
Summary report: N
BEND-IRON F/PL 2.4-3.5 L145
MDR report key: 2861825
·
Received December 7, 2012
Report
- Report Number
- 8030965-2012-01497
- Event Type
- Malfunction
- Date Received
- December 7, 2012
- Date of Event
- November 7, 2012
- Report Date
- November 8, 2012
- Manufacturer
- SYNTHES GMBH
- Product Code
- KWP
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL NARRATIVE: DEVICE USED FOR TREATMENT. THE DEVICE WAS RETURNED AND THE INVESTIGATION IS BEGINNING.
Description of Event or Problem · 1
A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: THE BENDING IRON HAS RUST ON THE SURFACE. THE INSTRUMENT HAS RUST DIFFERENT PLACES ESPECIALLY BY THE ARTICLE NUMBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BEND-IRON F/PL 2.4-3.5 L145 | BEND-IRON | KWP | SYNTHES GMBH | 1703233 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |