FDA Adverse Event Injury Summary report: N

PRESTIGE CERVICAL DISC SYSTEM

MDR report key: 8468007 · Received March 31, 2019

Report

Report Number: 1030489-2019-00365
Event Type: Injury
Date Received: March 31, 2019
Date of Event: February 18, 2019
Report Date: June 30, 2019
Manufacturer: WARSAW ORTHOPEDICS
Product Code: MJO
PMA / PMN Number: SEE H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TW
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS PART IS NOT APPROVED FOR SALE IN THE US BUT A SIMILAR PART WITH CATALOGUE# 6961660 AND PMA# P060018 AND UDI# (B)(4) IS APPROVED FOR SALE 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.

Additional Manufacturer Narrative · 1

PRODUCT ANALYSIS: ONE OF THE HOLES THAT MATES WITH AND LOCATES THE INSERTER HAS BROKEN OFF. BOTH THE FRACTURE SURFACE AND THE REPORTED EVENT ARE CONSISTENT WITH OVERLOAD FROM FORCE DURING IMPLANTATION. THE SMALL PORTION THAT WAS BROKEN OFF WAS NOT RETURNED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT CERVICAL DISC ARTHROPLASTY DUE TO HERNIATED INTERVERTEBRAL DISC. INTRA-OP, AFTER FINISHING DISCECTOMY, WHEN THE SURGEON PUT PRESTIGE IN THE DISC SPACE AND HAMMERED IT, THE IMPLANT BROKE. NO FRAGMENT OF THE BROKEN PRODUCT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
261191	PRESTIGE CERVICAL DISC SYSTEM	PROSTHESIS, INTERVERTEBRAL DISC	MJO	WARSAW ORTHOPEDICS	NA	0664363W

Patients

Seq	Age	Sex	Outcome	Treatment
1