MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. STRUT, MEDIUM, 08MM; INFIX SYSTEM

Catalog Number 1804-308

Device Problem Disassembly (1168)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3012447612-2018-00018 thru 3012447612-2018-00021.

Event Description

It was reported that the two struts of the construct backed out of location after installation while the surgeon was installing a second, similar construct at the adjacent level.The construct was removed and replaced with an alternative construct.There were no reports of patient impacts.This is report four of four for this event.

Manufacturer Narrative

The returned strut was evaluated.The strut is fully assembled with the mating end plate so it can not be disassembled to be individually assessed.However, there are no signs of damage or failures detected on the strut.The part and lot numbers of the returned struts are unable to be verified in their assembled state.The dhr is unable to be reviewed since the lot number is unknown.

• Brand Name: STRUT, MEDIUM, 08MM
• Type of Device: INFIX SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 7171997
• MDR Text Key: 96638057
• Report Number: 3012447612-2018-00021
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK031672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1804-308
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 113