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

Model Number	102-9800
Medical Device Problem Codes	Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection confirmed both tips of the driver were completely sheared off.It was stated that the failure occurred when trying to deploy the implant.When the driver is not fully seated onto the top of the implant and only half the tip interfaces into the spindle, any additional lateral movement during implant deployment, a large lateral applied force could result in the observed sheared driver tips.A review of the instructions for use (ifu) was performed and it did not reveal any anomalies as it states risks associated with lumbar spine surgery include: instruments used during surgery may break or malfunction which may cause damage to the operative site or adjacent structures.
Event or Problem Description
It was reported that during the superion indirect decompression system (ids) implant procedure, the driver prongs broke off and became lodged in the inserter after the spacer was placed.The physician had difficulty removing the driver from the inserter and the broken off driver prongs were successfully flushed and suctioned out of the patient which prolonged the procedure by fifteen minutes.
Event or Problem Description
It was reported that during the superion indirect decompression system (ids) implant procedure, the driver prongs broke off and became lodged in the inserter after the spacer was placed.The physician had difficulty removing the driver from the inserter and the broken off driver prongs were successfully flushed and suctioned out of the patient which prolonged the procedure by fifteen minutes.
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.Visual inspection confirmed both tips of the driver were completely sheared off.It was stated that the failure occurred when trying to deploy the implant.When the driver is not fully seated onto the top of the implant and only half the tip interfaces into the spindle, any additional lateral movement during implant deployment, a large lateral applied force could result in the observed sheared driver tips.A review of the instructions for use (ifu) was performed and it did not reveal any anomalies as it states risks associated with lumbar spine surgery include: instruments used during surgery may break or malfunction which may cause damage to the operative site or adjacent structures.
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.Additional information provided in block h11: visual inspection confirmed both tips of the driver were completely sheared off.It was stated that the failure occurred when trying to deploy the implant.When the driver is not fully seated onto the top of the implant and only half the tip interfaces into the spindle, any additional lateral movement during implant deployment, a large lateral applied force could result in the observed sheared driver tips.A review of the instructions for use (ifu) was performed and it did not reveal any anomalies as it states to avoid application of excessive stress on instrumentation.Additionally, the ifu 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 driver prongs broke off and became lodged in the inserter after the spacer was placed.The physician had difficulty removing the driver from the inserter and the broken off driver prongs were successfully flushed and suctioned out of the patient which prolonged the procedure by fifteen minutes.

• 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): VERTIFLEX INC; carlsbad CA 92010
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22178873
• Report Number: 3006630150-2025-04175
• Device Sequence Number: 8678504
• Product Code: NQO
• UDI-Device Identifier: 00884662000574
• UDI-Public: (01)00884662000574(17)241216(10)193833
• 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): Unknown
• 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): 08/05/2025

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 Expiration Date: 12/16/2024
• Device Model Number: 102-9800
• Device Catalogue Number: 102-9800
• Device Lot Number: 193833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 06/10/2025; 07/08/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 06/18/2025; 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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