FDA Adverse Event Injury Summary report: N

ZEPHIR ANTERIOR CERVICAL SYSTEM

MDR report key: 6217601 · Received January 3, 2017

Report

Report Number: 1030489-2017-00011
Event Type: Injury
Date Received: January 3, 2017
Report Date: November 17, 2016
Manufacturer: MDT SOFAMOR DANEK PUERTO RICO MFG
Product Code: KWQ
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 # 8792815, 510K # K030327 WAS CLEARED IN THE UNITED STATES. (B)(4). 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. FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

IT WAS REPORTED THAT ON (B)(6) 2014, PATIENT UNDERWENT CERVICAL ANTERIOR DECOMPRESSION FUSION AT LEVELS C2/3, C4/5 DUE TO PRE-OP DIAGNOSIS AS CERVICAL SPONDYLOSIS. ON AN UNKNOWN DATE, POST-OP, POOR SPINAL ALIGNMENT WAS OBSERVED DUE TO CAGE SUBSIDENCE. SCREW BACKED OUT. ON (B)(6) 2016, REVISION SURGERY, POSTERIOR DECOMPRESSION FUSION WAS PERFORMED FOR NEUROLOGIC SYMPTOM DUE TO POOR SPINAL ALIGNMENT. THERE WAS DELAY IN THE OVERALL PROCEDURE TIME BY MORE THAN 60 MINUTES. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
772	ZEPHIR ANTERIOR CERVICAL SYSTEM	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY	KWQ	MDT SOFAMOR DANEK PUERTO RICO MFG	NA	H11H2677

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention