MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SUPERION INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number	100-9814
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced migration of the implant and return of the preexisting pain.Radiography confirmed a slight migration of the device to be a/p, anterior-posterior displacement.During the revision procedure, the physician attempted multiple times to loosen the implant using the driver, on the final attempt it was noted the prongs on the driver were bent.A new driver was used to successfully loosen the implant; however, the physician was unable to remove the implant.The implant was retightened, and the case aborted.The patient was referred to a spine surgeon to explant the migrated implant device.
Additional Manufacturer Narrative
Date of event: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device component involved in the event: product family: superion instruments, upn: 102-9800, model: 102-9800, serial: n/a, batch: 204052.

• Brand Name: SUPERION INTERSPINOUS SPACER
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): VERTIFLEX INC; 2714 loker ave. west; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13390050
• Report Number: 3006630150-2022-00248
• Device Sequence Number: 12011803
• Product Code: NQO
• UDI-Device Identifier: 00884662000284
• UDI-Public: 00884662000284
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P140004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/01/2023
• Device Model Number: 100-9814
• Device Catalogue Number: 100-9814
• Device Lot Number: 800040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2018
• 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: Male
• Patient Race: White