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

Model Number 102-9800

Device Problem Material Integrity Problem (2978)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2024

Event Type  malfunction  

Event Description

It was reported that the driver broke during an implant procedure.The physician attempted to remove the implant and place a new one; however, remnants of the driver remained in the implant preventing the removal.The device remains implanted and deployed in the patient.The patient did well postoperatively.

Event Description

It was reported that the driver broke during an implant procedure.The physician attempted to remove the implant and place a new one; however, remnants of the driver remained in the implant preventing the removal.The device remains implanted and deployed in the patient.The patient did well postoperatively.Additional information was received that the patient experienced a return of their pain.X-ray imaging taken in the field revealed that the driver piece had migrated.

• Brand Name: SUPERION IDS KIT
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 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: 19195174
• MDR Text Key: 341240408
• Report Number: 3006630150-2024-02638
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2024

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
• Device Operator: Health Professional
• Device Model Number: 102-9800
• Device Catalogue Number: 102-9800
• Device Lot Number: 40103942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 90 YR
• Patient Sex: Male