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