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

Model Number 101-9816

Device Problem Material Twisted/Bent (2981)

Patient Problems Fall (1848); Therapeutic Effects, Unexpected (2099); No Code Available (3191)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional suspect medical device component involved in the event: product family: superion implant, upn: 101-9814, model: 101-9814, serial: n/a, batch: 800256.

Event Description

It was reported that patient had a fall after lifting something heavy.The patient then experienced loss of efficacy.X-rays showed that the implant at l3/4 had a bent upper left cam lobe and that the implant at l4/5 had dislodged from the interspinous space.The patient underwent a revision procedure where the implant at l3/4 was removed and replaced with a new implant and the implant at l4/5 was removed.The patient was doing well post operatively.

Event Description

It was reported that patient had a fall after lifting something heavy.The patient then experienced loss of efficacy.X-rays showed that the implant at l3/4 had a bent upper left cam lobe and that the implant at l4/5 had dislodged from the interspinous space.The patient underwent a revision procedure where the implant at l3/4 was removed and replaced with a new implant and the implant at l4/5 was removed.The patient was doing well post operatively.

Manufacturer Narrative

The returned devices were analyzed and found; superion implant, lot number 800130.The cam-lobes were significantly bent.The damaged cam lobes suggest that the user likely exerted excessive force while attempting to deploy the implant against a rigid obstruction (spinous process) during the implant procedure.The complaint of the superion implant having a bent cam lobe was confirmed through product analysis.The probable cause has been traced to unintended use error caused or contributed to event.Superion implant, lot number 800256.The implant exhibits normal characteristics.The complaint of the implant became dislodged after patient fell could not be confirmed with testing of the product return as no problem has been detected.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; suite 100; valencia CA 91355
• MDR Report Key: 11121106
• MDR Text Key: 225252677
• Report Number: 3006630150-2020-06574
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000567
• UDI-Public: 00884662000567
• Combination Product (y/n): N
• PMA/PMN Number: P140004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101-9816
• Device Catalogue Number: 101-9816
• Device Lot Number: 800130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention