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

Model Number 101-9812

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2024

Event Type  malfunction  

Event Description

It was reported that during a superion indirect decompression system implant procedure the spindle cap on the implant dislodged from the saddle of the implant while using the driver.The broken spacer implant was replaced, and the procedure was completed successfully.The patient was doing well post-operatively.

Event Description

It was reported that during a superion indirect decompression system implant procedure the spindle cap on the implant dislodged from the saddle of the implant while using the driver.The broken spacer implant was replaced, and the procedure was completed successfully.The patient was doing well post-operatively.

Manufacturer Narrative

The returned spacer was analyzed and revealed that the spindle cap was completely sheared off from the implant body.The detachment of the spindle cap was due to excessive force.The damage to the implant indicates the break was likely due to deployment against resistance, such as bone, and or manipulation of the position of the device by gear shifting of the inserter.A product labeling review identified that the device was used per the instructions for use (ifu) product label.Additionally, it states should any resistance be encountered during deployment of the superion implant, it may be suggestive of interference between the implant and bony anatomy, e.G., lamina, hypertrophic spinous process, and, or suboptimal implant positioning.Do not attempt to manipulate the position of the device by gear-shifting the inserter, i.E., gross cranial, caudal, lateral articulation, fig.8h, as the mechanical advantage or leverage provided by the length of the inserter may be sufficient to damage the implant or surrounding anatomy and are among the risks associated with the procedure.

• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 18727545
• MDR Text Key: 336508333
• Report Number: 3006630150-2024-00752
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 40093565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2023
• 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: 82 YR
• Patient Sex: Male