MAUDE Adverse Event Report: ALPHATEC SPINE, INC. ATEC LATERAL INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	100-06185510-S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records found no manufacturing, processing, or design related irregularities.The implants were found to be properly manufactured and released in accordance with the device master record.An evaluation is not possible at this time.The device remains in-situ.If additional information is provided, a supplemental report will be completed.
Event or Problem Description
On (b)(6) 2021, a female patient underwent a lateral interbody fusion spinal surgery.Around 5 months postoperatively, radiographs revealed the implanted cage had fractured.No revision surgery has been scheduled.No patient injury reported.

• Brand Name: ATEC LATERAL INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 12558503
• Report Number: 2027467-2021-00066
• Device Sequence Number: 1320952
• Product Code: MAX
• UDI-Device Identifier: 00190376180052
• UDI-Public: (01)00190376180052
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 07/26/2021

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
• Operator of Device: No Information
• Device Model Number: 100-06185510-S
• Device Catalogue Number: 100-06185510-S
• Device Lot Number: 721938
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR