FDA Adverse Event
Injury
Summary report: N
UCENTUM
MDR report key: 8745550
·
Received June 28, 2019
Report
- Report Number
- 9612420-2019-00028
- Event Type
- Injury
- Date Received
- June 28, 2019
- Date of Event
- August 13, 2018
- Report Date
- June 25, 2019
- Manufacturer
- ULRICH GMBH & CO. KG
- Product Code
- NKB
- UDI-DI
- 04052536081202
- PMA / PMN Number
- K123717
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
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. REPORT IS BEING SUBMITTED PAST 30 DAY DEADLINE BASED ON RETROSPECTIVE REVIEW CONDUCTED 6/21/2019. ORIGINAL MDR (1 OF 5) FILED 8/29/2018.
Description of Event or Problem · 0
THE SURGEON WAS NOT ABLE TO SUCCESSFULLY IMPLANT THE SCREW; TWO SCREWDRIVERS BROKE WHILE TRYING BUT REMAINED INTACT. HE DECIDED TO REMOVE THE SCREW AND BROKE ANOTHER SCREWDRIVER TRYING TO DO SO AND SEVERAL PIECES OF METAL BROKE OFF FROM THE SCREWDRIVER BUT WERE RECOVERED AND RETURNED ALONG WITH THE DRIVERS. THE SURGEON WAS ABLE TO REMOVE THE SCREW USING A ROD AND LOCKING SCREW. REPORT 2/5.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 537604 | UCENTUM | SCREWDRIVER | NKB | ULRICH GMBH & CO. KG | CS 3825-01 | WSA14728145 | 04052536081202 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Hospitalization |