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
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records revealed no manufacturing or processing related irregularities.The trestle luxe plate was found to be properly manufactured and released in accordance with design specifications.Visual inspection found that one of the plates gold locking mechanisms had become bent/deformed.The outward bend is consistent with damaged caused by incomplete disengagement of the locking slide to allow screw extraction.Root cause of the plate backing off the patient cannot be determine.Multiple attempts to obtain additional information have been unsuccessful.
Event or Problem Description
Plate backed off as surgeon was inserting the screws.In the process the locking mechanism got bent and no longer functional.No patient harm.

• Brand Name: ANTERIOR CERVICAL PLATE ASSEMBLY, 1-LEVEL, 020 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: 8315742
• Report Number: 2027467-2019-00003
• Device Sequence Number: 2138011
• Product Code: KWQ
• UDI-Device Identifier: 00844856066922
• UDI-Public: (01)00844856066922(10)710746
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 01/09/2019

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: 71001-020
• Device Catalogue Number: 71001-020
• Device Lot Number: 710746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 02/07/2019
• 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