MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CLOSURE TOP; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 07.02010.001

Device Problem Migration (4003)

Patient Problem No Information (3190)

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.

Event Description

It was reported a closure top backed out of a pedicle screw post-operatively.No further information has been provided.This is report one of two for this event.

Event Description

It was reported a closure top backed out of a pedicle screw post-operatively.No further information has been provided.This is report one of two for this event.

Manufacturer Narrative

Added information to h6: component codes, type of investigation, investigation findings, investigation conclusions this follow-up report is being submitted to relay additional information.The complaint is unrefuted for the unreturned closure top torq lmtg vitality (pn: 07.02010.001) for the closure top backed out post-operation.The products were not returned, and no photos were provided.Medical records were not provided for review.Potential cause root cause can't be established, since the products were not returned.Dhr review and related actions lot numbers were not provided, therefore dhr review can't be reviewed.A follow-up report will be submitted if new information is received that changes the information provided in this report.Reference report 3012447612-2020-00614-1.

• Brand Name: CLOSURE TOP
• Type of Device: VITALITY SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10681121
• MDR Text Key: 211466987
• Report Number: 3012447612-2020-00613
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K150896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02010.001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1