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

Model Number	102-9800
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis of the returned driver revealed that the tips of the driver were completely sheared off, as confirmed during visual inspection.As such, this damage was sufficient to prevent functional testing in the laboratory.This confirmed damage to the driver was likely an unintended result of excessive force while using the device.A review of the instructions for use (ifu) was performed, it states to avoid application of excessive stress on instrumentation and do not force deployment or implant breakage or damage to bony structures may result.
Event or Problem Description
It was reported that during the superion indirect decompression system (ids) implant procedure, the prongs of the driver broke during deployment of the implant.The physician assessed that this damage was due to the patients narrow anatomy which caused some resistance.All broken pieces of the driver were removed from the patient successfully however, the procedure was aborted due to the patients difficult anatomy.
Event or Problem Description
It was reported that during the superion indirect decompression system (ids) implant procedure, the prongs of the driver broke during deployment of the implant.The physician assessed that this damage was due to the patients narrow anatomy which caused some resistance.All broken pieces of the driver were removed from the patient successfully however, the procedure was aborted due to the patients difficult anatomy.
Additional Manufacturer Narrative
A retroactive review of events within the quality system identified this record as requiring remediation, including reporting and submission of an initial emdr per applicable criteria.Boston scientific has opened a corrective and preventive action (capa 8647) investigation to determine the root cause for why an initial emdr was not previously submitted to the fda in accordance with boston scientific established mdr reporting process and fda adverse event reporting requirements.Information gained through these investigation efforts will be utilized to determine root cause and implement appropriate preventive action(s), as necessary.Fields h7 and h9 were updated.Device analysis of the returned driver revealed that the tips of the driver were completely sheared off, as confirmed during visual inspection.As such, this damage was sufficient to prevent functional testing in the laboratory.This confirmed damage to the driver was likely an unintended result of excessive force while using the device.A review of the instructions for use (ifu) was performed, it states to avoid application of excessive stress on instrumentation and do not force deployment or implant breakage or damage to bony structures may result.
Additional Manufacturer Narrative
A retroactive review of events within the quality system identified this record as requiring remediation, including reporting and submission of an initial emdr per applicable criteria.Boston scientific has opened a corrective and preventive action (capa 8647) investigation to determine the root cause for why an initial emdr was not previously submitted to the fda in accordance with boston scientific established mdr reporting process and fda adverse event reporting requirements.Information gained through these investigation efforts will be utilized to determine root cause and implement appropriate preventive action(s), as necessary.Fields h7 and h9 were updated.Device analysis of the returned driver revealed that the end of the driver was damaged, and the tips of the driver were completely sheared off, as confirmed during visual inspection.As such, this damage was sufficient to prevent functional testing in the laboratory.This confirmed damage to the driver was likely an unintended result of excessive force while using the device.A review of the instructions for use (ifu) was performed, it states to avoid application of excessive stress on instrumentation and do not force deployment or implant breakage or damage to bony structures may result.It also states to carefully inspect all instruments prior to and after use.Do not use an instrument that is visibly damaged.If an instrument appears damaged after use confirm that no broken fragments are retained in the patient.
Event or Problem Description
It was reported that during the superion indirect decompression system (ids) implant procedure, the prongs of the driver broke during deployment of the implant.The physician assessed that this damage was due to the patient's narrow anatomy which caused some resistance.All broken pieces of the driver were removed from the patient successfully; however, the procedure was aborted due to the patient's difficult anatomy.

• Brand Name: SUPERION IDS KIT
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22178876
• Report Number: 3006630150-2025-04257
• Device Sequence Number: 21002224
• Product Code: NQO
• UDI-Device Identifier: 00884662000574
• UDI-Public: (01)00884662000574(17)280129(10)40027366
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2025

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 Model Number: 102-9800
• Device Catalogue Number: 102-9800
• Device Lot Number: 40027366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 06/10/2025; 07/31/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 06/19/2025; 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1972-2023
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Race: White