MAUDE Adverse Event Report: ALPHATEC SPINE INC ANTERIOR CERVICAL PLATE ASSEMBLY, 5-LEVEL, 085 MM (TI-6AI-4V ELI, NITINOL); SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	71005-085
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual examination of the returned 5-level plate found that one of the 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 anterior side of the plate contains witness marks at the graft windows on both sides of the detached blocking slide.The combination of these witness marks confirms the plate bending instrument was positioned inconsistent with ifu requirements while contouring/bending the plate.Additionally, the bend is positioned at one end of the plate rather than incrementally placed as suggested in the stg.
Event or Problem Description
Surgeon was bending plate correctly and once he put it in the patient a piece of the locking mechanism fell off.

• Brand Name: ANTERIOR CERVICAL PLATE ASSEMBLY, 5-LEVEL, 085 MM (TI-6AI-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: 9279280
• Report Number: 2027467-2019-00052
• Device Sequence Number: 19733985
• Product Code: KWQ
• UDI-Device Identifier: 00844856067240
• UDI-Public: (01)00844856067240(10)713351
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2019

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: Health Professional
• Device Model Number: 71005-085
• Device Catalogue Number: 71005-085
• Device Lot Number: 713351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR