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

Model Number 101-9812

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 03/07/2022

Event Type  Injury  

Event Description

It was reported that shortly following a superion indirect decompression spacer implant procedure, the patient had experienced a new, constant pain in the sacroiliac area.The patient's pain had ran down both legs.The physician had the patient get an x ray and it showed that the spacer had dislodged from it's original location.The patient's spacer was subsequently explanted as a result.The explanted spacer will not be returned for analysis, as it was discarded by the medical facility.

Event Description

It was reported that shortly following a superion indirect decompression spacer implant procedure, the patient had experienced a new, constant pain in the sacroiliac area.The patient's pain had ran down both legs.The physician had the patient get an x ray and it showed that the spacer had dislodged from it's original location.The patient's spacer was subsequently explanted as a result.

Manufacturer Narrative

Correction to the initial mdr in blocks: d6b and g4.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 14345834
• MDR Text Key: 291288414
• Report Number: 3006630150-2022-02129
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000543
• UDI-Public: 00884662000543
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 28460941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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