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

Model Number 101-9810

Device Problem Material Integrity Problem (2978)

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

Event Date 10/07/2022

Event Type  malfunction  

Event Description

It was reported that during an indirect decompression (id) implant procedure, the physician had implanted the spacer at the incorrect vertebral level.Upon extracting it, the physician broke the implant, damaging the spindle cap.It is unknown if the inserter was properly connected to the implant.The broken spacer was removed and a different sized spacer was used at the correct vertebral level to complete the procedure successfully.

Manufacturer Narrative

Correction made to block b2.Device analysis performed on the returned indirect decompression spacer was unable to confirm the reported event of damage to the implant or spindle cap.The implant exhibitied normal device characteristics during testing.A labeling review did not reveal any anomalies as it states to not force deployment and avoid application of excessive force onto the device or implant breakage may result.Therefore, engineers concluded that there was no problem detected with the returned device.

Event Description

It was reported that during an indirect decompression (id) implant procedure, the physician had implanted the spacer at the incorrect vertebral level.Upon extracting it, the physician broke the implant, damaging the spindle cap.It is unknown if the inserter was properly connected to the implant.The broken spacer was removed and a different sized spacer was used at the correct vertebral level to complete the procedure successfully.

• 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: 15719951
• MDR Text Key: 306891941
• Report Number: 3006630150-2022-05944
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000536
• UDI-Public: 00884662000536
• 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: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101-9810
• Device Catalogue Number: 101-9810
• Device Lot Number: 29360263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2022
• 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: 85 YR
• Patient Sex: Male
• Patient Race: White