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	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device returned for analysis and a visual inspection found that the end of the driver was damaged, and the tip of the driver was completely sheared off.Field return samples from complaints spike were sent for scanning electron microscopy (sem) analysis, material composition, and hardness testing.Analysis results indicate the failure is associated to presence of excessive hydrogen in the instrument material.Additionally, a review of the instructions for use (ifu) was performed and it did not reveal any anomalies as it states that excessive stress on instrumentation should be avoided, to not force deployment or implant breakage or damage to bony structures may result, among other risks associated with the procedure.
Event or Problem Description
It was reported that during the superion indirect decompression system (ids) implant procedure, there were difficulties deploying the implant, accompanied by a cracking sound, after which the implant would no longer turn.The driver had broken, and fragments became lodged in the implant.There were no signs of excessive force, sagittal movement, or gear-shifting during the procedure, however resistance may have been caused by thick bone or osteophytes.All broken pieces were successfully removed.The procedure was successfully completed without further issues.
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.The device returned for analysis and a visual inspection found that the end of the driver was damaged, and the tip of the driver was completely sheared off.Field return samples from complaints spike were sent for scanning electron microscopy (sem) analysis, material composition, and hardness testing.Analysis results indicate the failure is associated to presence of excessive hydrogen in the instrument material.Additionally, a review of the instructions for use (ifu) was performed and it did not reveal any anomalies as it states that excessive stress on instrumentation should be avoided, to not force deployment or implant breakage or damage to bony structures may result, among other risks associated with the procedure.
Event or Problem Description
It was reported that during the superion indirect decompression system (ids) implant procedure, there were difficulties deploying the implant, accompanied by a cracking sound, after which the implant would no longer turn.The driver had broken, and fragments became lodged in the implant.There were no signs of excessive force, sagittal movement, or gear-shifting during the procedure, however resistance may have been caused by thick bone or osteophytes.All broken pieces were successfully removed.The procedure was successfully completed without further issues.
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.The device returned for analysis and a visual inspection found that the end of the driver was damaged, and the tip of the driver was completely sheared off.The damage to the driver was sufficient to prevent functional testing.Field return samples from complaints spike were sent for scanning electron microscopy (sem) analysis, material composition, and hardness testing.Analysis results indicate the failure is associated to presence of excessive hydrogen in the instrument material.Additionally, a review of the instructions for use (ifu) was performed and it did not reveal any anomalies as it states that excessive stress on instrumentation should be avoided, to 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, there were difficulties deploying the implant, accompanied by a cracking sound, after which the implant would no longer turn.The driver had broken, and fragments became lodged in the implant.There were no signs of excessive force, sagittal movement, or gear-shifting during the procedure, however resistance may have been caused by thick bone or osteophytes.All broken pieces were successfully removed.The procedure was successfully completed without further issues.

• 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: 22179054
• Report Number: 3006630150-2025-04239
• Device Sequence Number: 15887746
• Product Code: NQO
• UDI-Device Identifier: 00884662000574
• UDI-Public: (01)00884662000574(17)280201(10)40029126
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/13/2025

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: 08/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 06/10/2025; 07/23/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 06/19/2025; 08/13/2025
• 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 Age: 83 YR
• Patient Sex: Male