MAUDE Adverse Event Report: ALPHATEC SPINE, INC. ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	51060-30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The screw has not returned for evaluation.It is unknown if revision surgery occurred.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.Any required fields left blank were not known at the time of submission.
Event or Problem Description
A patient underwent an anterior lumbar interbody fusion procedure on (b)(6) 2020.As the patient gradually resumed daily activities, he began to experience numbness and tingling.The pain progressed and became unbearable.Around 10 months postoperatively, the patient was informed that the pedicle screws had broken.

• Brand Name: ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM
• 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; carlsbad, CA 92008 ; 7603566777
• MDR Report Key: 23058170
• Report Number: 2027467-2025-00191
• Device Sequence Number: 9225225
• Product Code: KWQ
• UDI-Device Identifier: 00844856036956
• UDI-Public: (01)00844856036956(10)8247402
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 09/15/2025

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: 51060-30
• Device Lot Number: 8247402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 09/15/2025
• 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: Other
• Patient Age: 40 YR
• Patient Sex: Male