FDA Adverse Event
Injury
Summary report: N
MPR WING RETRACTOR
MDR report key: 10075675
·
Received May 19, 2020
Report
- Report Number
- MW5094610
- Event Type
- Injury
- Date Received
- May 19, 2020
- Date of Event
- September 16, 2019
- Report Date
- May 15, 2020
- Manufacturer
- UNK
- Product Code
- GAD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NJ, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE TIP (PIN) OF THE SUPERIOR ACETABULAR PLACED DIAMOND WING RETRACTOR BROKE OFF IN THE PATIENT'S PELVIC BONE. TIP WAS LEFT IN SITU DUE TO RISKS OF RETRIEVAL VS LOW POTENTIAL FOR COMPLICATIONS IF LEFT IN PLACE. PLACEMENT CONFIRMED VIA IMAGING AND PATIENT HAS BEEN EDUCATED. MEDICAL PRODUCTS RESOURCE, US. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 532052 | MPR WING RETRACTOR | RETRACTOR | GAD | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Disability |