MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INSIGNIA ANTERIOR CERVICAL PLATE SYSTEM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	136-0358
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned; therefore, an evaluation is not possible at this time.There has not been a revision surgery scheduled at this time.
Event or Problem Description
Post operatively, it was noticed in x-rays that the locking mechanism for the plate has popped off.There has not been any revision surgery scheduled at this time.Screws have not backed out.

• Brand Name: INSIGNIA ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 11838534
• Report Number: 2027467-2021-00029
• Device Sequence Number: 14223325
• Product Code: KWQ
• UDI-Device Identifier: 00190376268606
• UDI-Public: (01)00190376268606(11)200725
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 136-0358
• Device Catalogue Number: 136-0358
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/17/2021
• 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: 47 YR