MAUDE Adverse Event Report: ALPHATEC SPINE, INC ASPIDA; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	51060-25
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 3 months post-operatively, a patient underwent revision surgery to remove non-alpahtec posterior fixation hardware which failed.During the revision, the patient had a 2-level alif construct with plates implanted.Approximately 9 months postoperatively, a radiograph revealed broken screws.Revision surgery has not been scheduled.
Additional Manufacturer Narrative
Revision surgery has not occurred.No device evaluation is possible.The identifying lot number was not provided; therefore, a review of the device history record could not be conducted.Multiple attempts were unsuccessful in obtaining additional information related to this event.If additional information is received, a supplemental report will be submitted.

• Brand Name: ASPIDA
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283963
• MDR Report Key: 14720509
• Report Number: 2027467-2022-00039
• Device Sequence Number: 5025957
• Product Code: KWQ
• UDI-Device Identifier: 00844856063013
• UDI-Public: 00844856063013
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K101255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2022

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
• Device Model Number: 51060-25
• Device Catalogue Number: 51060-25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown