FDA Adverse Event
Malfunction
Summary report: N
UCENTUM
MDR report key: 5968006
·
Received September 21, 2016
Report
- Report Number
- 9612420-2016-00009
- Event Type
- Malfunction
- Date Received
- September 21, 2016
- Date of Event
- August 29, 2016
- Report Date
- September 21, 2016
- Manufacturer
- ULRICH GMBH & CO. KG
- Product Code
- NKB
- PMA / PMN Number
- K123717
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 0
ULRICH MEDICAL GMBH (MANUFACTURER) IS SUBMITTING THIS REPORT FOR BOTH ULRICH MEDICAL GMBH AND ULRICH MEDICAL USA (IMPORTER) EXEMPTION # E2014011
Description of Event or Problem · 0
SCREW BREAKAGE.
Description of Event or Problem · 1
SCREW BREAKAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 619302 | UCENTUM | SCREW, POLYAXIAL, 7.5MM, LENGTH 50MM | NKB | ULRICH GMBH & CO. KG | CS 3802-075-050 | U004218 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |