FDA Adverse Event Injury Summary report: N

EXPEDIUM ROD, 480 MM

MDR report key: 3812813 · Received May 15, 2014

Report

Report Number: 1526439-2014-11510
Event Type: Injury
Date Received: May 15, 2014
Report Date: April 24, 2014
Manufacturer: DEPUY SYNTHES SPINE
Product Code: NKB
PMA / PMN Number: PK033901
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE GIVEN TO PATIENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE ORIGINAL SURGERY WAS PERFORMED IN (B)(6) 2013 FOR DEGENERATIVE SCOLIOSIS, T10-PELVIS INSTRUMENTATION WITH EXPEDIUM 5.5 TITANIUM IMPLANTS. NON-UNION LED TO THREE 6X45MM SCREWS BREAKING AT RIGHT S1, LEFT L5 AND S1. ALSO, THERE WAS A BROKEN ROD AT RIGHT S1 AND A BROKEN LEFT ILIAC 40MM CONNECTOR. THE SAMPLES WERE GIVEN TO THE PATIENT. THE FOLLOWING MFG. MEDWATCH REPORTS ARE BEING FILED FOR THE THREE SCREWS, ONE ILIAC CONNECTOR, AND ONE ROD THAT ARE REPORTED TO HAVE BROKEN: 1526439-2014-11506; 1526439-2014-11507; 1526439-2014-11508; 1526439-2014-11509; 1526439-2014-11510.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
290301	EXPEDIUM ROD, 480 MM	ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	NKB	DEPUY SYNTHES SPINE

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR		Required Intervention