MAUDE Adverse Event Report: ALPHATEC SPINE INC ANTERIOR CERVICAL PLATE ASSEMBLY, 2-LEVEL, 026 MM (TI-6AI-4V ELI, NITINOL); SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	71002-026
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No evaluation possible at this time.The international customer has not returned the device for evaluation.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
Event or Problem Description
When placing the plate and inserting the screws for tightening, the secure central golden piece jumped.Fortunately, it was retrieved with no consequences to the patient.Finally, a new plate was used instead.No patient harm reported.
Additional Manufacturer Narrative
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 positioned inconsistent with ifu requirements while contouring/bending the plate.

• Brand Name: ANTERIOR CERVICAL PLATE ASSEMBLY, 2-LEVEL, 026 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: 8451790
• Report Number: 2027467-2019-00012
• Device Sequence Number: 13788442
• Product Code: KWQ
• UDI-Device Identifier: 00844856066977
• UDI-Public: (01)00844856066977(10)697688
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K102820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

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: 71002-026
• Device Catalogue Number: 71002-026
• Device Lot Number: 697688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 04/30/2019
• 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