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 Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 07/24/2020

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 3012447612-2020-00475 to 3012447612-2020-00484.

Event Description

It was reported that a patient underwent a revision surgery to address psuedoarthrosis and during the procedure it was discovered that the right s1 vitality pedicle screw was broken.The screw was removed and replaced with an alternate larger diameter screw to complete the case.There were no additional patient impacts reported.This is report six of ten for this event.

Manufacturer Narrative

Visual examination of the returned vitality screws identified that one of the screws has fully snapped, with the shaft disconnected from the screw head/tulip.The others appear to be without deformities.Functional investigation with 40 mm rod p142562 and closure top pn:07.02010.001 ln: w449491 showed that all tulip heads could thread and hold closure tops with rods.Visual examination of the returned vitality closure tops identified that the caps have been used before.Functional investigation with tulip head and screw pn: 701m6545 ln:t09925 and 40 mm rod p142562 showed that all four caps were fully functional.The complaint is confirmed.Review of the device history records for the four screws identified no deviations or anomalies during manufacturing.Lot identification is necessary for review of device history records, and lot identification could not be determined for the closure tops or the rods.Devices are used for treatment.The reported products were reviewed for compatibility with no issues noted.Review of complaint history identified additional similar complaints for the pn 07.02000.074 and 07.02000.075 and no additional complaints for the reported part and lot combinations.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Review of complaint history identified additional similar complaints for the pn 07.02010.001.However, as the lot number is unknown, an additional review could not be performed.Review of complaint history identified no additional similar complaints for the pn 07.02015.005.However, as the lot number is unknown, an additional review could not be performed.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

Event Description

It was reported that a patient underwent a revision surgery to address pseudoarthrosis and during the procedure it was discovered that the right s1 vitality pedicle screw was broken.The screw was removed and replaced with an alternate larger diameter screw to complete the case.There were no additional patient impacts reported.This is report six of ten for this event.

• 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: 10440326
• MDR Text Key: 203991265
• Report Number: 3012447612-2020-00480
• 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: 10/15/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 07.02010.001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 89