FDA Adverse Event
Malfunction
Summary report: N
SGL TRIG PIN COLLET 3.0 - 4.2MM
MDR report key: 2082618
·
Received April 27, 2011
Report
- Report Number
- 1811755-2011-01458
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- March 31, 2011
- Report Date
- April 1, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MFR FOR INVESTIGATION. BASED ON THE QUALITY INVESTIGATION, THE IMPREGLON COATING ON THE DEVICE WAS WORN OFF. THIS CONDITION COULD CAUSE THE DEVICE TO NOT RETAIN A PIN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WOULD NOT RETAIN A PIN. IT IS UNK IF THERE WAS PT INVOLVEMENT OR ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT. NO FURTHER INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SGL TRIG PIN COLLET 3.0 - 4.2MM | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |