FDA Adverse Event
Malfunction
Summary report: N
STRATUM FOOT PLATING SYSTEM
MDR report key: 10683200
·
Received October 15, 2020
Report
- Report Number
- 3009540749-2020-00036
- Event Type
- Malfunction
- Date Received
- October 15, 2020
- Date of Event
- September 10, 2020
- Report Date
- October 15, 2020
- Manufacturer
- NEXTREMITY SOLUTIONS
- Product Code
- HRS
- PMA / PMN Number
- K182201
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
DEVICE HISTORY RECORDS RELATED TO THE EVENT WERE REVIEWED. THERE WERE NO NON-CONFORMANCES DETECTED THROUGH THE DEVICE HISTORY RECORD REVIEW. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS PROVIDED IN THE FUTURE.
Description of Event or Problem · 1
IT WAS REPORTED DURING A SURGERY, USING THE STRATUM FOOT PLATING SYSTEM ON (B)(6) 2020, THE BLUE PLASTIC ALIGNMENT CAPS BROKE WHEN THE SURGEON WAS INSERTING THE DRILL SLEEVE. ALL BROKEN PIECES WERE REMOVED. PATIENT OUTCOME REPORTED AS BEING CONSISTENT WITH MID FOOT FUSIONS, WITH NO SIDE EFFECTS OR INFECTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1150250 | STRATUM FOOT PLATING SYSTEM | PLATE | HRS | NEXTREMITY SOLUTIONS | M1328 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR |