MAUDE Adverse Event Report: ALPHATEC SPINE INC ANTERIOR CERVICAL PLATE ASSEMBLY, 4-LEVEL, 068 MM (TI-6AI-4V ELI, NITINOL); SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number 71004-068

Device Problems Break (1069); Detachment Of Device Component (1104); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2016

Event Type  malfunction  

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 4-level plate found that the middle blocking slide had become completely detached from the implant.Witness marks along both the anterior and posterior sides 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 positioned inconsistent with ifu requirements 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 Description

The locking slide broke off two separate 4-level trestle luxe plates while bending.The second plate was implanted but a screw/anchor was not inserted at the location where the locking slide was missing.The event caused no patient issue.

• Brand Name: ANTERIOR CERVICAL PLATE ASSEMBLY, 4-LEVEL, 068 MM (TI-6AI-4V ELI, NITINOL)
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• Manufacturer Contact: richard welch ; 5818 el camino real; carlsbad, CA 92008 ; 7604946611
• MDR Report Key: 5796308
• MDR Text Key: 50520110
• Report Number: 2027467-2016-00046
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00844856067196
• UDI-Public: 00844856067196
• 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: Other
• Type of Report: Initial
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 71004-068
• Device Catalogue Number: 71004-068
• Device Lot Number: 694230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2015
• 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