MAUDE Adverse Event Report: ALPHATEC SPINE INC ANTERIOR CERVICAL PLATE ASSEMBLY, 2-LEVEL, 024MM (TI-6AL-4V NITINOL); KWQ

Model Number 71002-024

Device Problems Bent (1059); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2013

Event Type  malfunction  

Event Description

Surgeon bent plate and gold locking mechanism came off when implanted.

Manufacturer Narrative

Mdr being submitted as a result of a retrospective complaint review.Visual examination of the trestle luxe plate found one of the blocking slides 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 countering/bending.The plate contains a single witness mark on the posterior side directly behind the location of the detached blocking slide and two witness marks at the graft window 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.

• Brand Name: ANTERIOR CERVICAL PLATE ASSEMBLY, 2-LEVEL, 024MM (TI-6AL-4V NITINOL)
• Type of Device: KWQ
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: vernon trimble ; 5818 el camino real; carlsbad, CA 92008 ; 7604946648
• MDR Report Key: 4862469
• MDR Text Key: 5811874
• Report Number: 2027467-2015-00082
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• PMA/PMN Number: K102820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 71002-024
• Device Catalogue Number: 71002-024
• Device Lot Number: 649938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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 Outcome(s): Other
• Patient Age: 54 YR