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

Model Number	101-9812
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the implant procedure the device broke while being opened.Thick bone obstruction causing resistance was noted during the procedure.The device was correctly connected to the inserter.The broke device was removed and the procedure was completed successfully using a new device.
Event or Problem Description
It was reported that during the implant procedure the device broke while being opened.Thick bone obstruction causing resistance was noted during the procedure.The device was correctly connected to the inserter.The broke device was removed and the procedure was completed successfully using a new device.
Additional Manufacturer Narrative
The returned spacer was analyzed and revealed that the spindle cap was completely sheared off from the implant body.The detachment of the spindle cap was due to excessive force.The damage to the implant indicates failure was likely due to deployment against resistance bone and or manipulation of the position of the device by gear shifting of the inserter.Therefore, the root cause of the reported clinical observations is unintended use error caused or contributed to event.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12708657
• Report Number: 3006630150-2021-06028
• Device Sequence Number: 13952257
• Product Code: NQO
• UDI-Device Identifier: 00884662000543
• UDI-Public: 00884662000543
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P140004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2026
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 27771035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• 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
• Patient Sex: Male
• Patient Race: White