MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. 5.5 TI 8.5X90MM TRANSLATION SCREW; POLARIS SPINAL SYSTEM -TRANSLATION SCREW

Catalog Number 14-578690

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

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

Event Date 01/10/2024

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 polaris translation screw splayed and disassembled when putting the set screw on intra-operatively.The doctor removed it and replaced it with a polaris iliac screw.There was no patient impact; however, there was a two hour delay to remove and replace the screw.

Event Description

It was reported that a polaris translation screw splayed and disassembled when putting the set screw on intra-operatively.The doctor removed it and replaced it with a polaris iliac screw.There was no patient impact; however, there was a two hour delay to remove and replace the screw.

Manufacturer Narrative

Corrections in d4: lot number.Additional information in d4: udi number and h4.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: 5.5 TI 8.5X90MM TRANSLATION SCREW
• Type of Device: POLARIS SPINAL SYSTEM -TRANSLATION SCREW
• 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: 18595396
• MDR Text Key: 333965449
• Report Number: 3012447612-2024-00018
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140123
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-578690
• Device Lot Number: 2555951
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2016
• 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: Male
• Patient Ethnicity: Non Hispanic