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	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the driver broke during the superion indirect decompression system (ids) implant procedure.All broken fragments were successfully removed.There were no signs of excessive force, sagittal movement, or gear-shifting during the procedure, and no bone or osteophytes were present to cause resistance.The patient did not experience any reported complications.The damaged product was replaced and sent for analysis, and the procedure was completed without further issues.
Additional Manufacturer Narrative
Analysis of the returned driver revealed that the end of the driver was damaged and completely sheared off.The damage to the driver was sufficient to prevent functional testing.Scanning electron microscopy (sem) analysis, material composition, and hardness testing revealed the device anomaly is associated to the presence of excessive hydrogen in the instrument material, likely due to a manufacturing deficiency.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.An urgent medical device correction (97003015-fa) was delivered to physicians in may 2023 communicating the potential for superion indirect decompression system (ids) driver instrument tip breaks to occur with use of excessive force during the implant procedure.Driver tip damage may be readily detected via visual, audible, and/or tactile signals.Analysis of the returned driver revealed that the end of the driver was damaged and completely sheared off.The damage to the driver was sufficient to prevent functional testing.Scanning electron microscopy (sem) analysis, material composition, and hardness testing revealed the device anomaly is associated to the presence of excessive hydrogen in the instrument material, likely due to a manufacturing deficiency.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 the driver broke during the superion indirect decompression system (ids) implant procedure.All broken fragments were successfully removed from the patient and the procedure was completed successfully with a new driver.There were no reported patient complications.
Event or Problem Description
It was reported that the driver broke during the superion indirect decompression system (ids) implant procedure.All broken fragments were successfully removed from the patient and the procedure was completed successfully with a new driver.There were no reported patient complications.
Additional Manufacturer Narrative
Correction to the follow-up 1 mdr in block h6 and h11.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.An urgent medical device correction (97003015-fa) was delivered to physicians in (b)(6)communicating the potential for superion indirect decompression system (ids) driver instrument tip breaks to occur with use of excessive force during the implant procedure.Driver tip damage may be readily detected via visual, audible, and/or tactile signals.Analysis of the returned driver revealed that the end of the driver was damaged and completely sheared off.The damage to the driver was sufficient to prevent functional testing.Scanning electron microscopy (sem) analysis, material composition, and hardness testing revealed the device anomaly is associated to the presence of excessive hydrogen in the instrument material, likely due to a manufacturing deficiency.Additionally, a labeling review was performed and revealed no anomalies.The instructions for use (ifu) states to avoid application of excessive stress on instrumentation and do not force deployment or implant breakage or damage to bony structures may result.Furthermore, it indicates instruments should be carefully inspected prior to and after use; and not to use an instrument that is visibly damaged.If an instrument appears damaged after use it should be confirmed that no broken fragments are retained in the patient.

• 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: 22178879
• Report Number: 3006630150-2025-04222
• Device Sequence Number: 8678505
• Product Code: NQO
• UDI-Device Identifier: 00884662000574
• UDI-Public: (01)00884662000574(17)280201(10)40029126
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 11/18/2025

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: 40029126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 06/10/2025; 11/03/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 06/18/2025; 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• 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 Sex: Unknown
• Patient Race: White