FDA Adverse Event Malfunction Summary report: N

CHRONOS(TM) BETA-TCP WEDGE 10 DEG/RECTANGULAR-STERILE

MDR report key: 5323983 · Received December 23, 2015

Report

Report Number: 8030965-2015-12526
Event Type: Malfunction
Date Received: December 23, 2015
Report Date: December 3, 2015
Manufacturer: SYNTHES OBERDORF
Product Code: MQV
PMA / PMN Number: PK043045
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SD, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: FMF. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE WAS NOT IMPLANTED OR EXPLANTED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 18.JUN.2014 EXPIRY DATE: 01.OCT.2018, NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

IT WAS REPORTED THAT WHEN A CHRONOS WEDGE WAS OPENED FOR USE, THE ITEMS CRUMBLED RIGHT OUT OF THE PACKAGE. THE CHRONOS DID NOT MAINTAIN THE WEDGE SHAPE. THE CRUMBLED PRODUCT WAS NOT USED AND A DIFFERENT PRODUCT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO DELAY IN SURGERY AND NO PATIENT HARM NOTED. THERE IS NO ADDITIONAL INFORMATION. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
848506	CHRONOS(TM) BETA-TCP WEDGE 10 DEG/RECTANGULAR-STERILE	FILLER, CALCIUM SULFATE PREFORMED PELLETS	MQV	SYNTHES OBERDORF		9003394

Patients

Seq	Age	Sex	Outcome	Treatment
1