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

Catalog Number 07.02010.001

Device Problem Migration (4003)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 12/02/2020

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 3012447612-2020-00689, 3012447612-2020-00706, and 3012447612-2020-00707.

Event Description

It was reported there was a revision surgery to address patient pain associated with two closure tops that migrated out of their mating screws at l5 discovered five weeks post-op.The surgeon removed the two closure tops and the two corresponding pedicle screws.The surgeon replaced the screws with longer ones and replaced the closure tops.This is report two of four for this event.

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.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 there was a revision surgery to address patient pain associated with two closure tops that migrated out of their mating screws at l5 discovered five weeks post-op.The surgeon removed the two closure tops and the two corresponding pedicle screws.The surgeon replaced the screws with longer ones and replaced the closure tops.This is report two of four for this event.

Event Description

It was reported there was a revision surgery to address patient pain associated with two closure tops that migrated out of their mating screws at l5 discovered five weeks post-op.The surgeon removed the two closure tops and the two corresponding pedicle screws.The surgeon replaced the screws with longer ones and replaced the closure tops.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.Summary: the complaint is confirmed for two (2) of two (2) returned vitality closure tops (pn 07.02010.001) for the failure of post-op migration.This device is used for treatment.No medical records were provided with the complaint.Inspection: the specified identity of the devices was confirmed and the devices were examined.The closure tops were found to have signs of use, however there were no signs of damage.Photos of x-rays were also provided for review.The x-rays showed that the closure tops have migrated.The complaint is confirmed.Dhr review the dhrs were reviewed.There are no indications of manufacturing issues which would have contributed to this event and the devices were likely conforming when they left zimmer biomet¿s control.Potential root cause a definitive root cause cannot be determined with the information provided.During inspection of the returned parts it was found that there was thread damage on the tulip threads of one of the returned screws.There were no indications of manufacturing issues with the screw and there was no sign of damage on either of the returned closure tops, so the screw thread damage most likely happened during removal or at some point post-op after the closure top had migrated.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Manufacturer Narrative

Corrected information in h6: conclusions.An independent surgeon in the us reviewed the provided images and believes the cause is related to not having the rod seated/reduced fully down into the tulip of the pedicle screw when the closure top was final tightened because of the degree of the patient's spondylolisthesis, therefore preventing the closure tops from fully tightening in the pedicle screws and allowing for later migration.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

Event Description

It was reported there was a revision surgery to address patient pain associated with two closure tops that migrated out of their mating screws at l5 discovered five weeks post-op.The surgeon removed the two closure tops and the two corresponding pedicle screws.The surgeon replaced the screws with longer ones and replaced the closure tops.This is report two of four 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: 11088964
• MDR Text Key: 224114523
• Report Number: 3012447612-2020-00690
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02010.001
• Device Lot Number: W667291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Weight: 89