MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. BOTTOM LOADING POLY CLOSED ILIAC SCREW ASSEMBLIES 8.5X80MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 07.02012.166

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 09/10/2023

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 a distributor received an open iliac screw in a closed iliac screw package.There was no patient involvement.

• Brand Name: BOTTOM LOADING POLY CLOSED ILIAC SCREW ASSEMBLIES 8.5X80MM
• 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.; westminster CO 80021
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 17890264
• MDR Text Key: 325249570
• Report Number: 3012447612-2023-00307
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00889024003316
• UDI-Public: (01)00889024003316(10)416982
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 07.02012.166
• Device Lot Number: 416982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2017
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic