MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. SMALL CROSS CONNECTOR; EBI TOP LOADING MAS SPINAL FIXATION SYSTEM

Catalog Number 94671

Device Problem Material Deformation (2976)

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

Event Date 08/13/2023

Event Type  malfunction  

Event Description

It was reported that during final tightening of a small polaris cross connector, the set screw appeared to be stripped; no audible click was heard.The implant was taken off and a new one was used.There was no reported patient impact.

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.

• Brand Name: SMALL CROSS CONNECTOR
• Type of Device: EBI TOP LOADING MAS 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: 17711882
• MDR Text Key: 322974257
• Report Number: 3012447612-2023-00258
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00888480476320
• UDI-Public: (01)00888480476320(10)J6987546
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033312
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 94671
• Device Lot Number: J6987546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic