MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. TOP LOADING POLY SCREW ASSEMBLIES 6.5X50MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 07.02000.076

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/19/2023

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed to create more arthrodesis around some timberline cages because three screws were loose.The screws were removed and replaced.This is report one of three for this event.

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 3012447612-2023-00038 and 3012447612-2023-00039.

Manufacturer Narrative

H6: additional method code: 4110.Corrections in g1: additional information in h6: component, investigation type, findings and conclusions.Device evaluation: the device was not returned.And no photos were provided.So an evaluation is unable to be performed.Root cause: a definitive root cause cannot be determined, with the information provided.This event could possibly be attributed to unknown patient or surgical factors.Dhr review: the lot number was not provided.So, the dhr was unable to be reviewed.Device usage: this device is used for treatment.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, that a revision surgery was performed.To create more arthrodesis around some timberline cages, because three screws were loose.The screws were removed and replaced.This is report one of three for this event.

• Brand Name: TOP LOADING POLY SCREW ASSEMBLIES 6.5X50MM
• Type of Device: VITALITY SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16362951
• MDR Text Key: 309392340
• Report Number: 3012447612-2023-00037
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150896
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 07.02000.076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic