FDA Adverse Event Malfunction Summary report: N

TI ANTERIOR TENSION BAND PLATE

MDR report key: 2972391 · Received February 15, 2013

Report

Report Number: 2520274-2013-10369
Event Type: Malfunction
Date Received: February 15, 2013
Report Date: October 13, 2005
Manufacturer: SYNTHES (USA)
Product Code: KWQ
PMA / PMN Number: K022791
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATE 02/2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO SAMPLE WAS RETURNED FOR EVALUATION. THE LOT NUMBER IS UNK; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN, AS SAMPLE WAS NOT RECEIVED.

Description of Event or Problem · 1

PATIENT PARTICIPATED IN A MULTI-CENTER STUDY OF TREATMENT FOR 1 OR 2 LEVEL DEGENERATIVE DISC DISEASE BETWEEN L2 AND S1. PREOPERATIVE DIAGNOSIS WAS DISC FAILURE OR PROLAPSE, AND OSTEOPHYTIC SPONDYLOSIS (VERTEBRAL BODY). PT WAS IMPLANTED WITH AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPACER AT LEVEL L5_S1 SIZE. PT WAS ALSO IMPLANTED WITH AN ANTERIOR TENSION BAND (ATB) PLATE AT SCREW L5 ON LEFT, SCREW L5 ON RIGHT, SCREW S1 ON LEFT, AND SCREW S1 ON RIGHT, WITH ATB PLATE (B)(4). PT HAD BEEN EXPERIENCING PAIN FOR 300 MONTHS. SURGERY DATE WAS (B)(6) 2005, AND POSTOPERATIVELY PATIENT EXPERIENCED RIGHT SACROILIITIS, REQUIRING PHYSICAL THERAPY AND PAIN MEDICATIONS. THIS REPORT IS 1 OF 5 FOR THE SAME EVENT. THIS COMPLAINT IS ON THE ATB PLATE (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
69603	TI ANTERIOR TENSION BAND PLATE		KWQ	SYNTHES (USA)

Patients

Seq	Age	Sex	Outcome	Treatment
1