FDA Adverse Event Malfunction Summary report: N

CAPSTONE SPINAL SYSTEM

MDR report key: 7852230 · Received September 6, 2018

Report

Report Number: 1030489-2018-01212
Event Type: Malfunction
Date Received: September 6, 2018
Date of Event: September 5, 2018
Report Date: January 14, 2019
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Product Code: MAX
UDI-DI: 00613994846266
PMA / PMN Number: K103731
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

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: VISUAL AND OPTICAL INSPECTION OF THE THREADED INSERTER DID NOT REVEAL ANY NON-CONFORMANCES. FUNCTIONALLY TESTED THE THREADED INSERTER WITH A SAMPLE 2990001 INSERTER WITH NO ISSUES. NO FAULT FOUND. INSERTER IS CAPABLE OF PERFORMING ITS INTENDED FUNCTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

PROCEDURE: TRANSFORAMINAL LUMBAR INTERBODY FUSION PRE-OPERATIVE DIAGNOSIS: LUMBAR SPINAL CANAL STENOSIS LEVEL: L4-S IT WAS REPORTED THAT INTRA-OP, BREAKAGE OF THE SHAFT WAS CONFIRMED OUTSIDE THE PATIENT'S BODY. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PRODUCT FRAGMENTS REMAINED IN PATIENT. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
694840	CAPSTONE SPINAL SYSTEM	INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR	MAX	MEDTRONIC SOFAMOR DANEK USA, INC	NA	NM11M002	00613994846266

Patients

Seq	Age	Sex	Outcome	Treatment
1