MAUDE Adverse Event Report: ALPHATEC SPINE TRESTLE LUXE; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	71003-048
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned implant is currently under investigation.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
While attempting to bend the plate, one gold "locking tab" broke off the plate.This occurred on the back table.No patient involvement reported.
Additional Manufacturer Narrative
H6: investigation findings: 4248; investigation conclusions: 61.H10: visual examination of the returned 3-level plate found one of the locking mechanism (blocking slide) had become completely detached from the implant.Witness marks along posterior side of the plate are present and reveal the location of the instrument to plate during contouring/bending.The plate has a witness mark on the posterior side directly behind the location of the detached blocking slide.These witness marks confirm the plate bending instrument was positioned inconsistent with ifu requirements while contouring/bending the plate.Additionally, the bend is positioned at one end of the plate rather than incrementally placed as suggested in the stg.The blocking slide consists of three separate components which function as one mechanism upon assembly.The key feature which enables proper functionality is the male/female "dovetail" machined on both the plate and blocking slide components.Once correctly assembled the two mates cannot be disassembled unless one of the components are physically deformed/damaged.Labeling review: "intraoperative management: 3.When contouring the plate, great care should be taken not to scratch, notch or dent the surface as such deformities may compromise the strength of the implant.".

• Brand Name: TRESTLE LUXE
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): ALPHATEC SPINE; 1950 camino roble vida; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino roble vida; 9014283693
• MDR Report Key: 13362165
• Report Number: 2027467-2021-00084
• Device Sequence Number: 12027622
• Product Code: KWQ
• UDI-Device Identifier: 00844856067097
• UDI-Public: (01)00844856067097
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K102820
• 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): 12/29/2021

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: 71003-048
• Device Catalogue Number: 71003-048
• Device Lot Number: 721203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 03/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2020
• 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
• Patient Age: 67 YR
• Patient Sex: Male