MAUDE Adverse Event Report: ALPHATEC SPINE, INC. SEGMENTAL PLATING SYSTEM (SPS); APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	338-1-23518
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent an anterior cervical discectomy and fusion at levels c4-c7.Approximately four and a half months postoperatively, radiographic imaging revealed a broken screw at the c5 level.The patient is symptomatic, reporting discomfort at the level above the broken screw.Revision surgery is planned.
Additional Manufacturer Narrative
The implant remains in situ.Revision surgery is planned.Radiographic images were provided which confirm the event of a screw fracture.The identifying lot number was not provided; therefore, a review of device history records could not be performed.Based on the information provided the root cause could not be determined.Alphatec spine is submitting this report to comply with the fda regulations 21 cfr 803.Alphatec spine has made reasonable efforts to provide as much relevant information as available.Any field that is left blank was not known at the time of this submission.If additional information is provided, a supplemental report will be submitted.

• Brand Name: SEGMENTAL PLATING SYSTEM (SPS)
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: michael hendrickson ; 1950 camino vida roble; carlsbad, CA 92008 ; 7603566777
• MDR Report Key: 22108014
• Report Number: 2027467-2025-00104
• Device Sequence Number: 7122326
• Product Code: KWQ
• UDI-Device Identifier: 00190376536194
• UDI-Public: (01)00190376536194
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K233640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2025

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: Health Professional
• Device Model Number: 338-1-23518
• Device Catalogue Number: 338-1-23518
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown