FDA Adverse Event Malfunction Summary report: N

ZEPHIR ANTERIOR CERVICAL SYSTEM

MDR report key: 14345122 · Received May 10, 2022

Report

Report Number: 1030489-2022-00455
Event Type: Malfunction
Date Received: May 10, 2022
Date of Event: April 13, 2022
Report Date: May 10, 2022
Manufacturer: MDT SOFAMOR DANEK PUERTO RICO MFG
Product Code: KWP
UDI-DI: 00673978955278
PMA / PMN Number: K994239
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

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 SIMILAR DEVICE WITH PRODUCT ID: 8792115 WITH 510(K)#: K994239 IS MARKETED IN US. PRODUCT CODE OF SIMILAR DEVICE WITH PRODUCT ID: 8792115. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 0

INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT REVISION SURGERY FOR REMOVING THE SCREW/PLATE DUE TO SCREW-BACK-OUT AT C5/6. IT WAS REPORTED THAT THE C6 LEFT SCREW WAS BACKED-OUT DUE TO THE BROKEN C6 LEFT SCREW STOPPER AND WAS REMOVED. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE IMPLANT DATE AND EXPLANT DATE OF SCREW IS (B)(6) 2011 AND (B)(6) 2022. THE SCREW WAS DISCARDED BY THE CUSTOMER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1743552	ZEPHIR ANTERIOR CERVICAL SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	MDT SOFAMOR DANEK PUERTO RICO MFG	G8792115	UNKNOWN	00673978955278

Patients

Seq	Age	Sex	Outcome	Treatment
1		Male