TSRH SPINAL SYSTEM

Report

Report Number: 1030489-2021-01083
Event Type: Malfunction
Date Received: August 24, 2021
Report Date: August 24, 2021
Manufacturer: WARSAW ORTHOPEDICS
Product Code: KWP
PMA / PMN Number: SEE H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS PART IS NOT APPROVED FOR MARKET IN THE US. HOWEVER, A LIKE DEVICE WITH PART# 8293420, 510K# K031967 AND UPN# 00721902925320 IS MARKETED IN THE US. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING USE OF REPORTED PRO DUCTS. IT WAS REPORTED THAT DUE TO ADJACENT SEGMENT DISEASE, ALL WERE REMOVED ON THE REPORTED DAY, AND PLIF WAS PERFORMED ADDITIONALLY AT L4-5, AND FIXATION WAS PERFORMED AT L2-3-4-5. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2018, PLIF WAS PERFORMED AT L3-4. THE INITIAL SURGERY WAS PERFORMED WITH PRODUCTS TSRH RP2. THE SCREWS WERE LOOSE. THE SCREWS ARE OF FIRST USE AND SHOULD NOT BE TOO LOOSE, BUT THEY WERE LOOSE. SINCE THE SYMPTOM DEVELOPED IN THE ADJACENT VERTEBRAE, IT WAS DECIDED TO EXTEND THE FIXATION, AND SINCE IT WAS DIFFICULT TO EXTEND IT WITH TSRH-RP2, IT WAS REPLACED WITH SOLERA AND EXTENDED FIXATION WAS PERFORMED. THE PRODUCTS WERE USED ACCORDING TO IFU/LABELLING. THE STATUS OF PRODUCTS WAS MENTIONED AS ¿EXPLANTED ¿ COMPLETE¿. THE EVENT DATE WAS MENTIONED AS ASKED BUT, UNKNOWN. NO FURTHER COMPLICATIONS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1259768	TSRH SPINAL SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	WARSAW ORTHOPEDICS	G9010001575	0653428W

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR