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

Model Number	136-0236
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned device is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
Screw backed out of plate.Revision surgery required to replace plate.
Additional Manufacturer Narrative
Additional information has been provided regarding this compliant investigation.H3.Yes.H6.Medical device problem code: 3083.Component code: 3026.Type of investigation: 10; 3331.Investigation findings:170.Investigation conclusions: 23.H7.Recall.H9.2027467-4/16/2021-r.H10.Atec initiated a recall 2027467-4/16/2021-r on 04/16/2021 as well as cap-000400 for the insignia system.Review of the returned insignia plate and screws shows signs and wear consistent with the known failure modes associated the hhe 2021-003 and cap-000400 which resulted in 2027467-4/16/2021-r.The blocker torque measured using blocker torque measured using torque gauge torqtrn-003.Blocker #1: lock= 1.77 oz/in.Unlock = 1.28 oz/in.Lock= 1.77 oz/in.Blocker #2: lock 9.02 oz/in.Unlock 10.16 oz/in.Lock 11.26 oz/in.Blocker #3: lock 6.32 oz/in.Unlock 5.20.Lock 6.95.The root cause is likely resistance of the rotational force/torsion is under specification.There was no patient injury reported for this event.

• Brand Name: INSIGNIA ANTERIOR CERVICAL PLATE SYTEM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 11786201
• Report Number: 2027467-2021-00023
• Device Sequence Number: 11633202
• Product Code: KWQ
• UDI-Device Identifier: 00190376268385
• UDI-Public: (01)00190376268385(10)8609314R
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K200995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 136-0236
• Device Catalogue Number: 136-0236
• Device Lot Number: 8609314R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 10/07/2021
• 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: Required Intervention