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

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2018

Event Type  malfunction  

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 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.

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)
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 8451790
• MDR Text Key: 140311347
• Report Number: 2027467-2019-00012
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00844856066977
• UDI-Public: (01)00844856066977(10)697688
• Combination Product (y/n): N
• PMA/PMN Number: K102820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other