MAUDE Adverse Event Report: ALPHATEC SPINE, INC IDENTITI ALIF STANDALONE INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	132-10-85-300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implant remains in-situ.The lot number was not provided.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
A postoperative radiograph revealed a sa graft bolt fractured.No revision surgery planned at this time.No patient injury reported.
Additional Manufacturer Narrative
H10.The graft bolt is a component of the alphatec identiti alif standalone interbody system, which is an integrated intervertebral body fusion device for use in anterior lumbar interbody fusion (alif) procedures used in patients for treatment, not diagnosis.The index surgery date is unknown.Communication was received from a sales representative reporting postoperative radiographs revealed a graft bolt fracture.He indicated surgical intervention is not planned as the implant is holding in proper position.The postoperative radiograph images were not provided to alphatec.The identifying lot number was not provided.The patient's bone quality, medical history, and postoperative physical activity is unknown.Based on the information provided, a root cause cannot be determined.If additional information is made available, a supplemental report will be submitted.Labeling review: 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.On -05-dec-2022, the fda sent alphatec additional information request for this mdr.Alphatec responded to the fda on 13-jan-2023.

• Brand Name: IDENTITI ALIF STANDALONE INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 12849211
• Report Number: 2027467-2021-00075
• Device Sequence Number: 4018334
• Product Code: OVD
• UDI-Device Identifier: 00190376299730
• UDI-Public: 00190376299730
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K203742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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
• Device Model Number: 132-10-85-300
• Device Catalogue Number: 132-10-85-300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown