MAUDE Adverse Event Report: ALPHATEC SPINE, INC. ANTERIOR CERVICAL PLATE ASSEMBLY, 1-LEVEL, 020 MM (TI-6AI-4V ELI, NITINOL); SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number 71001-020

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

Patient Problem No Information (3190)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

No evaluation possible at this time.The implant has not been returned for evaluation.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.

Event Description

During the surgery, the plate was coming off the bone as the surgeon was attempting to insert the screws.In the process, the locking mechanism got bent and became none functional.

• Brand Name: ANTERIOR CERVICAL PLATE ASSEMBLY, 1-LEVEL, 020 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 younger ; 5818 el camino real; carlsbad, CA 92008 ; 7604946842
• MDR Report Key: 7582196
• MDR Text Key: 110875733
• Report Number: 2027467-2018-00035
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00844856066922
• UDI-Public: (01)00844856066922(10)710746
• 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: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 71001-020
• Device Catalogue Number: 71001-020
• Device Lot Number: 710746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/22/2017
• 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: 59 YR