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	07/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the returned driver revealed that the end of the driver tips were broken off and completely sheared off.The damage to the driver was sufficient to prevent functional testing.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally, labeling states avoid application of excessive stress on instrumentation, including insert driver through the proximal entry point on the inserter, gently rotating until the distal end of the driver is engaged to the implant among other risks associated with the procedure.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.
Event or Problem Description
It was reported that prior to completing the superion indirect decompression (id) procedure, the physician assessed that the driver prongs had sheared off next to the id implant.The physician using forceps, confirmed all driver pieces were removed before completing the procedure.The patient did well post-operatively.
Event or Problem Description
It was reported that prior to completing the superion indirect decompression (id) procedure, x-ray imaging revealed artifacts next to the implants spindle cap.The physician assessed that the driver prongs had sheared off next to the id implant.The physician using forceps, confirmed all driver pieces were removed before completing the procedure.The patient did well post-operatively.
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.Analysis of the returned driver revealed that the end of the driver tips were broken off and completely sheared off.The damage to the driver was sufficient to prevent functional testing.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally, labeling states avoid application of excessive stress on instrumentation, including insert driver through the proximal entry point on the inserter, gently rotating until the distal end of the driver is engaged to the implant among other risks associated with the procedure.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.
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.Analysis of the returned driver revealed that the driver was damaged and both tips of the driver were sheared off.The damage to the driver was sufficient to prevent functional testing.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally, labeling states avoid application of excessive stress on instrumentation and not to force deployment or implant breakage or damage to bony structures may result.The ifu 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, the ifu instructs to confirm that no broken fragments are retained in the patient.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.
Event or Problem Description
It was reported that prior to completing the superion indirect decompression (id) procedure, x-ray imaging revealed artifacts next to the implants spindle cap.The physician assessed that the driver prongs had sheared off next to the id implant.The physician using forceps, confirmed all driver pieces were removed before completing the procedure.The patient did well post-operatively.

• 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: 22179062
• Report Number: 3006630150-2025-04242
• Device Sequence Number: 13196507
• Product Code: NQO
• UDI-Device Identifier: 00884662000574
• UDI-Public: (01)00884662000574(17)280329(10)40049533
• 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
• 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): 07/29/2025

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: 40049533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• 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; 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2023
• 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: 72 YR
• Patient Sex: Female