MAUDE Adverse Event Report: ALPHATEC SPINE INC ANTERIOR CERVICAL PLATE ASSEMBLY, 2-LEVEL, 028MM (TI-6AL-4V ELI, NITINOL); SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	71002-028
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records revealed no manufacturing, processing or design related irregularities.The trestle luxe plate was found to be properly manufactured and released in accordance with the device master record.Visual examination of the returned 2-level plate found that the middle blocking slide had become completely detached from the implant.Witness marks along both the anterior and posterior sides of the plate are present and reveal the location of the instrument to plate during contouring/bending.The plate contains a witness mark on the posterior side directly behind the location of the detached blocking slide and witness marks at both graft windows on the anterior side.The combination of these witness marks confirms the plate bending instrument was improperly positioned while contouring/bending the plate.Alphatec surgical technique (lit-84315) provides instructions as to proper plate contouring.It also provides caution to reduce/eliminate the risk of this type of event.Caution: do not place the anvil portion of the plate bender over the blocking slide as damage can occur and affect its function.The provided instructions for use (ins-048) state; intraoperative management: trestle luxe 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.
Event or Problem Description
Locking mechanism is sheared off the instrument.No patient involved.

• Brand Name: ANTERIOR CERVICAL PLATE ASSEMBLY, 2-LEVEL, 028MM (TI-6AL-4V ELI, NITINOL)
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 5596065
• Report Number: 2027467-2016-00022
• Device Sequence Number: 10827204
• Product Code: KWQ
• UDI-Device Identifier: 00844856066984
• UDI-Public: 00844856066984
• Combination Product (Y/N): N
• PMA/510(K) Number: K102820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2016

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: Physician
• Device Model Number: 71002-028
• Device Catalogue Number: 71002-028
• Device Lot Number: 690792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2016
• Initial Report FDA Received Date: 04/21/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other