MAUDE Adverse Event Report: ALPHATEC SPINE, INC. IDENTITI; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	100-08186010-S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implant remains in situ.The radiograph image received confirms the presence of two fractures in the spacer.The review of the device history record shows that the implant met all dimensional specifications at the time of manufacturing and successfully passed all inspection requirements, with no reported non-conformities.There were no manufacturing issues related to this product that could have contributed to the complaint condition.The root cause cannot be determined at this time.Labeling review: "warnings/cautions/precautions: potential risks identified with the use of these fusion devices, which may require additional surgery, include device component failure, loss of fixation, pseudarthrosis (i.E., non-union), fracture of the vertebra, neurological injury, and/or vascular or visceral injury." "possible adverse effects: possible adverse effects include: 1.Initial or delayed loosening, bending, dislocation, and/or breakage of device components." "postoperative management: postoperative management by the surgeon is essential.This includes instructing, warning, and monitoring the compliance of the patient.1.Patient should be informed regarding the purpose and limitations of the implanted devices.2.The surgeon should instruct the patient regarding the amount and time frame after surgery of any weight bearing activity.The increased risk of bending, dislocation, and/or breakage of the implanted devices, as well as an undesired surgical result are consequences of any type of early or excessive weight bearing, vibratory motion, falls, jolts or other movements preventing proper healing and/or fusion development.".
Event or Problem Description
During the 3-month postoperative visit, the patient underwent a ct scan which revealed the spacer which was implanted at l3-4 had broken in two places.The patient is experiencing pain.No additional action has been taken at this time.

• Brand Name: IDENTITI
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008
• MDR Report Key: 20250038
• Report Number: 2027467-2024-00116
• Device Sequence Number: 12590795
• Product Code: MAX
• UDI-Device Identifier: 00190376205076
• UDI-Public: (01)00190376205076(10)9591613
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191311
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2024

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 Model Number: 100-08186010-S
• Device Catalogue Number: 100-08186010-S
• Device Lot Number: 9591613
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2023
• 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
• Patient Sex: Male