FDA Adverse Event
Injury
Summary report: N
4 HOLE PIN CLAMP, RED MONOTUBE TRIAX 25 MM
MDR report key: 1635580
·
Received March 17, 2010
Report
- Report Number
- 8031020-2010-00031
- Event Type
- Injury
- Date Received
- March 17, 2010
- Date of Event
- February 26, 2010
- Report Date
- February 26, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- HXD
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. SAME PT EVENT AS MDR 8031020-2010-00030.
Description of Event or Problem · 1
ACCORDING TO THE SURGEON, THE PT CLAIMED THAT RED MONOTUBE HAS STRANGE SOUND. THE RED MONOTUBE IMPLANTED ON (B) (6) 2007, AS A REPLACEMENT OF THE PREVIOUSLY FRACTURED BLUE MONOTUBE. THE SURGEON PLANS TO REPLACE THIS RED MONOTUBE TO NEW RED MONOTUBE ON (B) (6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4 HOLE PIN CLAMP, RED MONOTUBE TRIAX 25 MM | IMPLANT | HXD | STRYKER OSTEOSYNTHESIS SELZACH | NA | P04778 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |