MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. BOTTOM LOADING POLY OPEN ILIAC SCREW ASSEMBLIES 8.5X80; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 07.02050.166

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Event Description

It was reported that an iliac screw disassembled during installation intra-operatively.The screw's shaft was removed and replaced with another iliac screw without patient impacts.

Manufacturer Narrative

Inspection: visual inspection revealed the tulip has disassembled from the screw shank.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could be attributed to off-axis forces applied during use.Device use: this device is used for treatment.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 that an iliac screw disassembled during installation intra-operatively.The screw's shaft was removed and replaced with another iliac screw without patient impacts.

• Brand Name: BOTTOM LOADING POLY OPEN ILIAC SCREW ASSEMBLIES 8.5X80
• 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: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 12748506
• MDR Text Key: 279992755
• Report Number: 3012447612-2021-00423
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889024009592
• UDI-Public: (01)00889024009592(10)416982
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150896
• 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: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02050.166
• Device Lot Number: 416982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female