MAUDE Adverse Event Report: ALPHATEC SPINE INC TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	71003-060
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
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
The locking mechanism popped off of a 60mm trestle luxe plate during surgery.
Additional Manufacturer Narrative
H3: yes.H6: medical device problem:2907.Medical device component: 907.Type of investigation: 10; 3331.Investigation findings:4248.Investigation conclusion: 19.H10: the implant was received, and a visual inspection was conducted which confirmed the middle blocking slide had become completely detached from the implant.The plate contains a witness mark on the posterior side directly behind the location of the detached blocking slide.The witness mark suggests the plate bending instrument was positioned inconsistent with ifu requirements while contouring/bending the plate.The device history record was reviewed for this pn/ln.Qty 9 plates were received on 04/02/2012 manufactured to drawing rev.C.The plates met all specification requirements and passed final inspection prior to being released into inventory.No patient injury was reported.Root cause appears to be the results of an incorrect plate bending technique.Witness marks confirm the plate bending instrument was positioned inconsistent with surgical technique guide requirements while contouring/bending the plate.

• Brand Name: TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): ALPHATEC SPINE INC; 1950 camino vida roble; carlsbad, CA 92008
• MDR Report Key: 12046924
• Report Number: 2027467-2021-00041
• Device Sequence Number: 11907563
• Product Code: KWQ
• UDI-Device Identifier: 00844856067134
• UDI-Public: 00844856067134
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 05/24/2021

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
• Operator of Device: No Information
• Device Model Number: 71003-060
• Device Lot Number: 646047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1