MAUDE Adverse Event Report: ALPHATEC SPINE, INC ATEC LATERAL INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	116-4-6545
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned device is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
Around 10 months postoperatively, radiographs revealed a self-retaining caudal screw had backed out of the plate.The locking mechanism arm on the plate also appeared to be broken.A revision surgery took place on (b)(6) 2022 to remove and replace the implants.
Additional Manufacturer Narrative
Corrected data.D4.Model# 116-4-6545; 116-2-06.Lot# 8711206; ct39363.Udi: (b)(4).H6: health effect- clinical code: 4582.Health effect- impact code: 4629.Medical device problem code:2923.Component code: 568.Type of investigation: 3331; 10.Investigation findings: 4248.Investigation conclusions: 24.Device evaluation: h10.A review of the device history records did not identify any manufacturing or processing-related irregularities related to the screw shank geometry, tulip geometry, or other physical features.The returned implants showed wear and damage consistent with the reported complaint and postoperative radiograph.The locking tabs on one screw hole are deformed and bent which allowed the bone screw to migrate rearwards.The postoperative radiograph indicates the plate and screws were used without supplemental fixation as is required per the instructions for use (ifu).The plate and screws are not indicated for, cleared, or tested to be used without supplemental fixation.Instructions for use: "the anti-migration plate (amp) is a lateral anti-migration plating system designed to be used with atec lateral interbody spacer systems to provide integrated fixation.The amp plate, bone screws and center screw are manufactured from titanium alloy (ti-6al-4v eli) per astm f136.Amp is intended for screw fixation to the thoracolumbar spine.Amp is not intended for standalone use and amp may be used with atec lateral interbody systems, identititm-lif, transcendtm-lif, and battalion® llif, to provide integrated fixation in addition to supplemental fixation.The instruments in this system are intended for use in surgical procedures.".

• Brand Name: ATEC LATERAL 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: 13546062
• Report Number: 2027467-2022-00004
• Device Sequence Number: 20137684
• Product Code: OVD
• UDI-Device Identifier: 00190376206097
• UDI-Public: 00190376206097
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K191311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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): 01/17/2022

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: 116-4-6545
• Device Catalogue Number: 116-4-6545
• Device Lot Number: 8711206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2020
• 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: 79 YR
• Patient Sex: Male