MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. 5.5 TI 7.5X35MM TRANSLATION SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	14-578535
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a polaris 5.5 translation screw broke from the screw housing post-operatively.This was discovered during a follow up with the patient due to her reporting pain.Removal and replacement of the construct is scheduled for early (b)(6) 2025.
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.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.
Event or Problem Description
It was reported that a polaris 5.5 translation screw broke from the screw housing post-operatively.This was discovered during a follow up with the patient due to her reporting pain.Removal and replacement of the construct was performed.
Additional Manufacturer Narrative
Corrections in b5 and d4: lot & udi numbers.Additional information in d6b and h4.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that a polaris 5.5 translation screw broke from the screw housing post-operatively.This was discovered during a follow up with the patient due to her reporting pain.Removal and replacement of the construct was performed.
Additional Manufacturer Narrative
H6: additional method code: 4110.Corrections in d9 and h3.Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the screw shank has fractured.Additionally, the provided x-rays show that the screw has fractured at the lower housing.Root cause: this event could possibly be attributed to unknown patient or surgical factors.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 highridge medical¿s control.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.

• Brand Name: 5.5 TI 7.5X35MM TRANSLATION SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW 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: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 21927274
• Report Number: 3012447612-2025-00160
• Device Sequence Number: 18328621
• Product Code: NKB
• UDI-Device Identifier: 00880304942745
• UDI-Public: (01)00880304942745(10)2586211
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140123
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 14-578535
• Device Lot Number: 2586211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 07/21/2025; 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic