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

Catalog Number 07.02010.001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 07/29/2020

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 3012447612-2020-00461 to 3012447612-2020-00474, 3012447612-2020-00495 and 3012447612-2020-00496.

Event Description

It was reported that a patient underwent a revision surgery to address psuedoarthrosis and back pain.During the procedure it was discovered that the right and left s1 vitality pedicle screws were broken.The screws were removed and replaced with alternate larger screws to complete the case.There were no additional patient impacts reported.This is report nine of sixteen for this event.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d10, g4, g7, h1, h2, h3, h10.

Event Description

It was reported that a patient underwent a revision surgery to address "pseudoarthrosis" and back pain.During the procedure it was discovered that the right and left s1 vitality pedicle screws were broken.The screws were removed and replaced with alternate larger screws to complete the case.There were no additional patient impacts reported.This is report nine of sixteen for this event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information and initially corrected information.The complaint is confirmed.Medical records were not provided for review.Device evaluation: the two vitality screw 6.5 x 40 item: 07.02000.074 are fractured as reported the complaint.The remaining returned items were tested but did not show signs of deformation and passed all functional tests.Potential cause root cause was unable to be determined.This event could possibly be attributed to a traumatic event post-op, failure to follow post-op care instructions, patient factors or other operating conditions that are not known.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.Reference reports 3012447612-2020-00461 to 3012447612-2020-00474, 3012447612-2020-00495, and 3012447612-2020-00496.

• 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: 10440478
• MDR Text Key: 203986773
• Report Number: 3012447612-2020-00469
• 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,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 07.02010.001
• Device Lot Number: W545991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Weight: 103