FDA Adverse Event
Malfunction
Summary report: N
LOCK-CAP FLAT ONE-STEP F/MATRIX 5.5 COCR
MDR report key: 3603151
·
Received February 3, 2014
Report
- Report Number
- 2520274-2014-00400
- Event Type
- Malfunction
- Date Received
- February 3, 2014
- Date of Event
- January 10, 2014
- Report Date
- January 10, 2014
- Manufacturer
- SYNTHES USA
- Product Code
- NKB
- PMA / PMN Number
- K120838
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES MNH, MNI, KWQ, AND KWP. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. PLACEHOLDER.
Description of Event or Problem · 1
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A THREAD FROM A LOCKING CAP 09.632.099 CAME FREE FROM THE CAP WHILE THE SURGEON WAS ATTEMPTING TO PLACE IT. IT DID NOT DELAY SURGERY, IT DID NOT EFFECT THE SURGICAL OUTCOME AND NO DAMAGE WAS DONE TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 71399 | LOCK-CAP FLAT ONE-STEP F/MATRIX 5.5 COCR | NKB | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |