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

Model Number	101-9816
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Fall (1848); Therapeutic Effects, Unexpected (2099); No Code Available (3191)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; suite 100; valencia CA 91355
• MDR Report Key: 11121106
• Report Number: 3006630150-2020-06574
• Device Sequence Number: 3923228
• Product Code: NQO
• UDI-Device Identifier: 00884662000567
• UDI-Public: 00884662000567
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P140004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/20/2024
• 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
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention