FDA Adverse Event Injury Summary report: N

VERTEX RECONSTRUCTION SYSTEM

MDR report key: 7863602 · Received September 11, 2018

Report

Report Number: 1030489-2018-01229
Event Type: Injury
Date Received: September 11, 2018
Date of Event: August 21, 2018
Report Date: September 11, 2018
Manufacturer: MEDTRONIC SOFAMOR DANEK
Product Code: KWP
PMA / PMN Number: SEE H10
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ALTHOUGH IT IS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES. THIS PRODUCT IS NOT AVAILABLE FOR MARKET IN THE US, HOWEVER A LIKE DEVICE WITH PART# 6958930, 510K# K042789 AND UDI (B)(4) IS AVAILABLE 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.

Description of Event or Problem · 1

PRE-OP DIAGNOSIS: INFECTION PROCEDURE: POSTERIOR CERVICAL SPINAL FUSION IT WAS REPORTED THAT POST-OP, THE PATIENT PRESENTED WITH INFECTION. ADDITIONAL SURGERY WAS SCHEDULED TO BE PERFORMED AS A RESULT OF THE EVENT. THE IMPLANTED DEVICE DID NOT BREAK. NO OTHER INFO WAS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
704124	VERTEX RECONSTRUCTION SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	MEDTRONIC SOFAMOR DANEK	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other\| R