FDA Adverse Event Injury Summary report: N

UNKNOWN SCREWS

MDR report key: 15221536 · Received August 12, 2022

Report

Report Number: 0008031020-2022-00390
Event Type: Injury
Date Received: August 12, 2022
Date of Event: December 22, 2021
Report Date: August 12, 2022
Manufacturer: STRYKER GMBH
Product Code: HWC
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THIS COMPLAINT HAS BEEN GENERATED BASED ON FINDINGS DISCOVERED DURING POST MARKET SURVEILLANCE LITERATURE REVIEW. THE ALLEGED EVENT OF SCREW LOOSENING COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR. MORE DETAILED INFORMATION ABOUT THE PATIENT MEDICAL HISTORY, THE EVENT CIRCUMSTANCES, RADIOGRAPHS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY.

Description of Event or Problem · 0

THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE ¿DEPARTMENT OF ORTHOPAEDIC SURGERY, (B)(6). THE TITLE OF THIS REPORT IS ¿DELAYED BLADDER PERFORATION DUE TO SCREW LOOSENING AFTER PELVIC RING INJURY SURGERY¿, PUBLISHED ON (B)(6) 2021, AND CAN BE FOUND AT HTTPS://DOI.ORG/10.20408/JTI.2021.0054. THE REPORT IS ASSOCIATED WITH THE STRYKER ¿MATTA PELVIC SYSTEM¿ AND INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 1 PATIENT. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A PRECISE DEVICE(S) IDENTIFICATION OR PATIENT INFORMATION; HOWEVER, THE ARTICLE ALLEGES THAT 1 PATIENT EXPERIENCED SCREW LOOSENING AFTER 6 MONTHS OF SURGERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1817059	UNKNOWN SCREWS	SCREW, FIXATION, BONE	HWC	STRYKER GMBH		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Other