FDA Adverse Event Injury Summary report: N

ZEPHIR ANTERIOR CERVICAL SYSTEM

MDR report key: 7057624 · Received November 24, 2017

Report

Report Number: 1030489-2017-02385
Event Type: Injury
Date Received: November 24, 2017
Date of Event: May 30, 2017
Report Date: November 24, 2017
Manufacturer: MDT SOFAMOR DANEK PUERTO RICO MFG
Product Code: KWQ
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

ALTHOUGH IT IS UNKNOWN IF ALL THE FOUR SCREWS MALFUNCTIONED AND LED TO THE EVENT OR NOT, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES. MENTIONED PART WAS USED IN THE EVENT WITH QUANTITY AS 4. THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 8792813, 510K# K073285 AND (B)(4) IS CLEARED FOR 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

IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION SURGERY AT C5-C7 DUE TO CERVICAL SPONDYLOTIC MYELOPATHY (CSM). POST-OP, AIRWAY OBSTRUCTION WAS DEVELOPED DUE TO HEMATOMA. HENCE, PATIENT UNDERWENT TRACHEOSTOMY. IMPLANTED PLATE AND SCREW WERE FOUND LOOSE AND UNSUCCESSFUL BONE UNION WAS ALSO OBSERVED POST-OPERATIVELY. PATIENT WAS SCHEDULED FOR INTERVENTION, HOWEVER, DUE TO PATIENT'S PHYSICAL CONDITION, IT WAS POSTPONED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
836550	ZEPHIR ANTERIOR CERVICAL SYSTEM	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY	KWQ	MDT SOFAMOR DANEK PUERTO RICO MFG	NA	H5254843

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Other\| R