MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ENDPLATE, SMALL, 3 DEGREES; INFIX ANTERIOR LUMBAR SYSTEM

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 03/12/2021

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 3012447612-2021-00113 to 3012447612-2021-00116.

Event Description

It was reported that during a 6 week follow up visit, x-rays showed that the construct located at l5/s1 was completely disassembled.The struts were no longer attached inside the endplates and were floating internally.A decision on further patient care has not yet been made.This is report two of four for this event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information and initially corrected information.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was reported that during a 6 week follow up visit, x-rays showed that the construct located at l5/s1 was completely disassembled.The struts were no longer attached inside the endplates and were floating internally.A revision surgery was performed on (b)(6) 2021.The surgeon removed original hardware and replaced it.This is report two of four for this event.

Manufacturer Narrative

Corrections in b5, h1, and h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the item was returned disassembled.There is no visual deformity on the items other than disassembly.Provided x-rays show the post-operative disassembly within the patient.Potential cause root cause was unable to be determined.This event could possibly be attributed to adverse post-operative events, patient factors or other unknown operational factors.Dhr review per dhr review, the parts were likely conforming when they left zimmer biomet control.Device use this device is used for treatment.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.

Event Description

It was reported that during a 6 week follow up visit, x-rays showed that the construct located at l5/s1 was completely disassembled.The struts were no longer attached inside the endplates and were floating internally.A revision surgery was performed to remove and replace the construct.This is report two of four for this event.

• Brand Name: ENDPLATE, SMALL, 3 DEGREES
• Type of Device: INFIX ANTERIOR LUMBAR SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11619175
• MDR Text Key: 243956721
• Report Number: 3012447612-2021-00114
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• PMA/PMN Number: K132790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1801-103
• Device Lot Number: PZ04B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR