FDA Adverse Event Injury Summary report: N

TSRH SPINAL SYSTEM

MDR report key: 5814991 · Received July 22, 2016

Report

Report Number: 1030489-2016-02156
Event Type: Injury
Date Received: July 22, 2016
Report Date: July 1, 2016
Manufacturer: WARSAW ORTHOPEDICS
Product Code: KWP
PMA / PMN Number: SEE H10
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PMA 510(K): THIS PRODUCT IS NOT APPROVED FOR SALE IN US BAT A SIMILAR PRODUCT WITH CATALOG #828-090 AND 510#K964275 IS APPROVED FOR SALE IN US. PATIENT CODE: (REVISION SURGERY). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT ON (B)(6) 2016 (DATE IS APRROX.), PATIENT UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L2-L5 DUE TO KYPHOSIS. POST-OP BOTH SIDE RODS FRACTURED AT L3/4 LEFT AND L4/5 RIGHT. BONE UNION AT L2 VERTEBRAL COLUMN RESECTION (VCR) HAD BEEN ACHIEVED BUT NOT YET AT FRACTURED PARTS, PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016 AND RODS WERE REPLACED AND FIXATION WAS DONE UNTIL T6 DUE TO ROD BREAKAGE. NO FRAGMENTS OF THE PRODUCTS REMAINED INSIDE THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
468289	TSRH SPINAL SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	WARSAW ORTHOPEDICS	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	SCREWS