FDA Adverse Event
Malfunction
Summary report: N
4 HOLE PIN CLAMP, RED MONOTUBE TRIAX 25M
MDR report key: 2050577
·
Received March 15, 2011
Report
- Report Number
- 8031020-2011-00067
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- August 18, 2010
- Report Date
- March 28, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- KTT
- PMA / PMN Number
- K910483
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS DISCARDED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE PHARMACIST AT THE HOSPITAL REPORTED THAT DURING A SURGERY, THE SCREW WAS STUCK IN THE MECHANISM. HE HAD TO REPEAT THE PROCEDURE A SECOND TIME. IT IS ALSO MENTIONED THAT THERE WERE NO ADVERSE CONSEQUENCES FOR THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4 HOLE PIN CLAMP, RED MONOTUBE TRIAX 25M | IMPLANT | KTT | STRYKER OSTEOSYNTHESIS SELZACH | NA | M18312 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |