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

Model Number	136-0242
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/22/2021
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
Revision surgery was conducted on (b)(6) 2021 to remove and replace an insignia 2 level plate.Post-op images taken 6 weeks after initial surgery revealed a screw blocking mechanism disassembled from the plate.The insignia 2 level plate was implanted on (b)(6) 2020.
Additional Manufacturer Narrative
Additional information: a2.(b)(6) 1957 (date of birth).A3.Male.H7: recall.H9.2027467-4/16/2021-r.Device evaluation: h6: medical device problem: 2907; 1069.Component code: 907.Investigation findings: 3211.Investigation conclusion: 4301.H10: the returned implant was evaluated by engineering.Results of the investigation were provided to compliance on (b)(6) 2021.Visual inspection showed wear consistent with parts that have been implanted and removed.The plate was returned with two intact blocking mechanisms with one missing that was not returned.There is damage on the top of plate consistent with that caused by a bur.Similar damage is also seen on two of the screw heads.This was most likely caused during the removal of the plate from the patient.The torques were measured for the remaining two blockers and pictures were taken of the components.Measure torque with torqtrn-003.Distal lock: 1.16 in-oz.Distal unlock: 1.11 in-oz.Medial lock: 11.50 in-oz.Medial unlock: 13.09 in-oz.The distal blocker was removed to check for abnormal wear or damage.During the removal process of the distal blocker the tab on part of the swage fractured.Wear was seen on the underside of the distal blocker wings most likely caused by rubbing on the head of the screws.The root cause is likely a result of the design feature limitations of strength/function.

• 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
• Manufacturer Contact: richard younger ; 1950 camino vida roble; carlsbad, CA 92008 ; 7604319286
• MDR Report Key: 11682725
• Report Number: 2027467-2021-00015
• Device Sequence Number: 14235124
• Product Code: KWQ
• UDI-Device Identifier: 00190376268415
• UDI-Public: (01)00190376268415(10)8663402
• 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 Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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: 136-0242
• Device Catalogue Number: 136-0242
• Device Lot Number: 8663402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 12/22/2021
• Date Device Manufactured: 09/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown