FDA Adverse Event Injury Summary report: N

ABGII MODULAR SHORT NECK

MDR report key: 2924543 · Received January 22, 2013

Report

Report Number: 0002249697-2013-00095
Event Type: Injury
Date Received: January 22, 2013
Date of Event: January 4, 2013
Report Date: January 4, 2013
Manufacturer: STRYKER ORTHOPAEDICS-MAHWAH
Product Code: MEH
PMA / PMN Number: K092406
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

Additional Manufacturer Narrative · 1

AN EVENT REGARDING ALTR INVOLVING AN ABGII MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. REVIEW OF DEVICE HISTORY RECORDS FOUND THE DEVICES IN THE REPORTED LOT WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE SUPER AND CHS COMPLAINT DATABASES SHOW THERE HAVE BEEN OTHER EVENTS FOR THE REPORTED LOT. SIMILAR EVENTS HAVE OCCURRED FOR THE CATALOG NUMBER AND PRODUCT FAMILY. THESE EVENTS WERE DETERMINED TO BE ASSOCIATED WITH RA 2012-067. VOLUNTARY RECALL RA 2012-067 WAS INITIATED FOR ABGII AND REJUVENATE MODULAR STEMS AND NECKS DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED ALTR IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL. NO FURTHER INVESTIGATION IS REQUIRED.

Description of Event or Problem · 1

IT WAS REPORTED THAT COMPONENTS WERE EXPLANTED DUE TO ADVERSE LOCAL TISSUE REACTION.

Description of Event or Problem · 1

IT WAS REPORTED THAT COMPONENTS WERE EXPLANTED DUE TO ADVERSE LOCAL TISSUE REACTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
30632	ABGII MODULAR SHORT NECK	IMPLANT	MEH	STRYKER ORTHOPAEDICS-MAHWAH		G3003327

Patients

Seq	Age	Sex	Outcome	Treatment
1	25 YR		Hospitalization\| O\| R