MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. CANNULATED POLYAXIAL SCREW 6.5MM X 40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	824M6540
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2026
Type of Reportable Event	Malfunction
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 intra-operatively, when attempting to insert the set screw into the right s1 pedicle screw, cross-threading occurred.The screw was upsized and replaced; however, although the rod and set screw were inserted, the screw came out of the bone.As a result, it was decided not to fix s1 and no screw was placed in the right s1.L3¿s1 fixation was planned, however fixation was completed from l3 to l5.There was a 45 minute delay but no other patient impact.This is report one of three for this event.

• Brand Name: CANNULATED POLYAXIAL SCREW 6.5MM X 40MM
• 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: 25196474
• Report Number: 3012447612-2026-00129
• Device Sequence Number: 16095653
• Product Code: NKB
• UDI-Device Identifier: 03662663237246
• UDI-Public: (01)03662663237246
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203507
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 05/16/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 824M6540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VITAL MIS ROD 5.5X100MM (815M1110)
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic