FDA Adverse Event Malfunction Summary report: N

IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

MDR report key: 4808593 · Received June 1, 2015

Report

Report Number: 2520274-2015-14126
Event Type: Malfunction
Date Received: June 1, 2015
Report Date: May 8, 2015
Manufacturer: SYNTHES USA
Product Code: JDP
PMA / PMN Number: PK110354
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL NARRATIVE: PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. EVENT DATE: UNKNOWN. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN LOCKING SCREWS. A PARTIAL PART NUMBER OF 02.231.XXX WAS PROVIDED. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE: HRS AND HWC. IMPLANT/EXPLANT: UNKNOWN. BASED OFF OF THE PARTIAL PART NUMBER FOR THIS COMPLAINANT PART, THE LIKELY 510K NUMBER IS K110354. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. 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 DURING A WEBEX DISCUSSION REGARDING A STUDY RELATED TO VARIABLE ANGLE (VA) CONDYLAR PLATE/SCREW CONNECTION STRENGTH THAT AN UNKNOWN QUANTITY OF SCREWS LOOSENED FROM A CONDYLAR PLATE. THE EVENT WAS DISCOVERED ON AN UNKNOWN DATE AT HERSHEY MEDICAL CENTER. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN LOCKING SCREWS. A PARTIAL PART NUMBER OF 02.231.XXX WAS PROVIDED. THIS REPORT IS 1 OF 1 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
352151		IMPLANT, FIXATION DEVICE, CONDYLAR PLATE	JDP	SYNTHES USA

Patients

Seq	Age	Sex	Outcome	Treatment
1