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

Device Problem Migration (4003)

Patient Problems Fall (1848); Pain (1994)

Event Date 05/01/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced a fall about eight months ago.Prior to the patients fall, the patients leg pain had resolved since the indirect decompression (id) spacer was implanted five years ago.However after the fall, the patients pain returned in her legs.An x-ray was performed to evaluate the position of the patients spacers.The physician determined that the spacers had moved posterior and the patient underwent a revision procedure to reposition the spacers.The patient was doing well post-operatively and the patients pain issue was resolved.

Event Description

It was reported that the patient experienced a fall about eight months ago.Prior to the patients fall, the patients leg pain had resolved since the indirect decompression (id) spacer was implanted five years ago.However after the fall, the patients pain returned in her legs.An x-ray was performed to evaluate the position of the patients spacers.The physician determined that the spacer had moved posterior and the patient underwent a revision procedure to reposition the spacer.The patient was doing well postoperatively.

• Brand Name: SUPERION INTERSPINOUS SPACER
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 18526308
• MDR Text Key: 333038246
• Report Number: 3006630150-2024-00092
• 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: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female