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

Catalog Number 1804-108

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 04/05/2017

Event Type  Injury  

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 3012447612-2017-00011 thru 3012447612-2017-00018.

Event Description

It was reported that two constructs at the l4-5 and l5-s1 levels failed to lock, resulting in the disc space collapsing 7 weeks after the constructs were implanted.A successful revision surgery was performed and the constructs were removed and competitive standalone anterior devices were placed.This is report eight of eight for this event.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Manufacturer Narrative

The returned strut was examined.There were visual indications that the strut was installed, but not locked into place within the plate.There were no signs of damage on the strut.The strut was mechanically assembled with the mating pieces and found to lock into place as expected.There were no device malfunctions detected.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain sufficient instructions regarding device assembly, including strut locking.

• Brand Name: STRUT, SMALL, 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: 6545807
• MDR Text Key: 74473280
• Report Number: 3012447612-2017-00018
• 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,Followup
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1804-108
• Device Lot Number: 83HY
• Other Device ID Number: (01)00889024331198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2017
• Initial Date FDA Received: 05/04/2017
• Supplement Dates Manufacturer Received: Not provided; 10/03/2017
• Supplement Dates FDA Received: 06/12/2017; 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2014
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR