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	Vertebral Fracture (4520)
Date of Event	06/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned driver was visually analyzed and revealed that a fragment of the driver tip was sheared off and lodged into the spacer implant.The damage to the driver tip is most likely due to subjecting the device to excessive force.A product labeling review identified that the device was used per the instructions for use ifu.Additionally, it states avoid application of excessive stress on instrumentation and do not use an instrument that is visibly damaged.
Event or Problem Description
It was reported that during a superion indirect decompression system implant procedure, both driver tips broke and became stuck in the implant during deployment.One of the driver tips was successfully removed by the implanting physician; however, the second driver tip could not be retrieved, and the entire implant had to be removed.In the process of removal, the lumber four superior spinous process was broken off.
Additional Manufacturer Narrative
A comprehensive 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's 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.The returned driver was visually analyzed and revealed that a fragment of the driver tip was sheared off and lodged into the spacer implant.The damage to the driver tip is most likely due to subjecting the device to excessive force.A product labeling review identified that the device was used per the instructions for use ifu.Additionally, it states avoid application of excessive stress on instrumentation and do not use an instrument that is visibly damaged.
Event or Problem Description
It was reported that during a superion indirect decompression system implant procedure, both driver tips broke and became stuck in the implant during deployment.One of the driver tips was successfully removed by the implanting physician; however, the second driver tip could not be retrieved, and the entire implant had to be removed.In the process of removal, the lumber four superior spinous process was broken off.
Additional Manufacturer Narrative
A comprehensive 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 scientifics 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.The returned driver was visually analyzed and revealed that a fragment of the driver tip was sheared off and lodged into the spacer implant.The damage to the driver tip is most likely due to subjecting the device to excessive force.Product analysis confirmed that the most probable cause of the complaint is unintended use error caused or contributed to event.A product labeling review identified that the device was used per the instructions for use ifu.Additionally, it states avoid application of excessive stress on instrumentation and do not use an instrument that is visibly damaged.It also states to carefully inspect all instruments prior to and after use.If an instrument appears damaged after use, confirm no broken fragments are retained in the patient.Spinous process fracture is also a known risk associated with use of lumbar spine implants and associated instruments.
Event or Problem Description
It was reported that during a superion indirect decompression system implant procedure, both driver tips broke and became stuck in the implant during deployment.One of the driver tips was successfully removed by the implanting physician; however, the second driver tip could not be retrieved, and the entire implant had to be removed.In the process of removal, the lumber four superior spinous process was broken off.

• 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: 22178907
• Report Number: 3006630150-2025-04223
• Device Sequence Number: 8841486
• Product Code: NQO
• UDI-Device Identifier: 00884662000574
• UDI-Public: (01)00884662000574(17)280103(10)40018363
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 40018363
• 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: 06/19/2023
• Supplement Date Received by Manufacturer: 06/10/2025; 08/29/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 06/18/2025; 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male