FDA Adverse Event Injury Summary report: N

ACC HEX ROD 5.5X480MM, SS

MDR report key: 3100030 · Received May 8, 2013

Report

Report Number: 1526439-2013-16773
Event Type: Injury
Date Received: May 8, 2013
Report Date: April 11, 2013
Manufacturer: DEPUY SYNTHES SPINE
Product Code: KWP
PMA / PMN Number: PK041119
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

IT WAS REPORTED THAT THE DEVICE WAS SENT TO THE HOSPITAL'S CENTRAL PROCESSING AND WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED AS THE LOT CODE IS UNKNOWN. WITHOUT A PRODUCT SAMPLE, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. REVIEW OF COMPLAINT DATA FOUND NO EMERGING TRENDS. IN THE ABSENCE OF A PRODUCT SAMPLE, LOT NUMBER, OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE COMPLAINT PRODUCT SAMPLE BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND THE PRODUCT EVALUATED. DEVICE NOT AVAILABLE.

Description of Event or Problem · 1

IT WAS REPORTED THAT AFTER INITIAL IMPLANT SURGERY, THE PATIENT SUSTAINED FALL AND CREATED LOAD ON TO THE CONSTRUCT, CAUSING ONE EXPEDIUM POLYAXIAL SCREW AND TWO EXPEDIUM RODS TO BREAK. REVISION SURGERY WAS PERFORMED AND THE DEVICES WERE EXPLANTED AND REPLACED. THIS REPORT IS BEING FILED FOR THE SECOND EXPEDIUM ROD THAT WAS INVOLVED IN THIS EVENT. SEE MFG MEDWATCH REPORT NO. 1526439-2013-16771 FOR THE EXPEDIUM POLYAXIAL SCREW THAT WAS INVOLVED IN THIS EVENT. SEE MFG MEDWATCH REPORT NO. 1526439-2013-16772 FOR THE FIRST EXPEDIUM ROD THAT WAS INVOLVED IN THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
200634	ACC HEX ROD 5.5X480MM, SS	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	DEPUY SYNTHES SPINE		UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention