FDA Adverse Event Injury Summary report: N

VERTEX RECONSTRUCTION SYSTEM

MDR report key: 7270487 · Received February 14, 2018

Report

Report Number: 1030489-2018-00211
Event Type: Injury
Date Received: February 14, 2018
Report Date: February 14, 2018
Manufacturer: MDT SOFAMOR DANEK PUERTO RICO MFG
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

THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6958724; (B)(4); THE 510K # K083071, WAS CLEARED IN THE UNITED STATES. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. X-RAY REVIEW: POST-OP X-RAYS FOR O-C2 FUSION DEMONSTRATE UNDERSIZED HARDWARE AT THE C2 LAMINA AND C1 LEVEL WAS CLIPPED. IT IS NOT SURE AS TO WHAT THE INTERACTION OF THIS CONSTRUCT WAS BUT IN THE ABSENCE OF BONY FUSION ON OA SUBLUXATION, IT IS SUSPECTED THAT THERE WAS INSUFFICIENT STABILIZATION AT THIS LEVEL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT UNDERWENT OC2 FIXATION FOR ATLANTOAXIAL SUBLUXATION. POST-OP, THE SCREW BACKED OUT. THERE IS A POSSIBILITY THAT THE BONE GRAFT WAS PRESSING THE NERVE. REOPERATION WAS PERFORMED IN WHICH C2 SCREW WAS REMOVED, DECOMPRESSION WAS CONFIRMED AND THE SCREW WAS INSERTED AT C3/4. THE BONE FROM THE ILIAC BONE WAS TRANSPLANTED TO NEAR C1 AGAIN AND WAS FIXED WITH NESPLON.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
113131	VERTEX RECONSTRUCTION SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	MDT SOFAMOR DANEK PUERTO RICO MFG	NA	H5309485

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Other