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

Model Number 711-0234

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/08/2022

Event Type  malfunction  

Event Description

The locking mechanism on a trestle luxe plate broke off intraoperatively.The plate was removed from the patient and a new one was implanted successfully.

Manufacturer Narrative

The implant is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.

Manufacturer Narrative

Ln sm126126.Unique identifier (udi)# (b)(4).D5.Health professional.H4.05/29/2020.H6.Investigation findings: 3243.Investigation conclusions: 18, 61.H10.The implant is used for treatment, not diagnosis.The dhr for this part was reviewed, and no non-conformances were noted in manufacturing, material, dimensions, and processes were all within specification.The plates met all specification requirements and passed final inspection prior to being released into inventory.Review of returned device confirms that the center blocking slide is completely detached from the plate.Further investigation shows witness marks that are consistent with plate bending on the anterior faces of the superior & inferior blocking slides, as well as witness marks on the anterior and posterior surfaces of the plate.The location of these witness marks suggest that the plate may have been improperly bent directly over the center blocking slide, inconsistent with the surgical technique guidelines while the contouring/bending the plate.Labeling review: "warnings/cautions: do not place the anvil portion of the plate bender over the blocking slide as damage can occur and affect its function.This product is a single use device.Under no circumstances should it be reused.While the device may appear to be undamaged, it may have small defects or internal stress patterns, as a result of the prior implantation or removal that could lead to fatigue failure.Additionally, please note that the removed implant has not been designed or validated so as to allow for decontamination of microorganisms.Reuse of this product could lead to cross-infection and/or material degradation as a result of the decontamination process.The company accepts no responsibility for implants which have been reused.Intraoperative management: trestle luxe and luxe ii anterior cervical plates are contoured to closely match the anatomical configuration of the spine.If the plate cannot be fitted and additional contouring is necessary, it is recommended that such contouring be minimal and be performed with the instrumentation provided.The plate must not be contoured in proximity of bone screw pockets or screw retention mechanism.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.".The root cause is likely a result of the plate bending technique by the user which caused physical damage of the plate and blocking slide components.

• Brand Name: TRESTLE LUXE
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 15366648
• MDR Text Key: 299687921
• Report Number: 2027467-2022-00056
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00190376215211
• UDI-Public: (01)00190376215211
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 711-0234
• Device Catalogue Number: 711-0234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2022
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female