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

Model Number	100-9810
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an explant procedure to explant the indirect decompression (id) spacer.The patient had gotten into a golf cart accident and broken one of the legs off the spacer.Although it was not easy to get the spacer out, the physician successfully explanted the spacer and the broken leg component.The patient was reimplanted with a new spacer at the same level and an additional new spacer was added at l 3-4 lumbar vertebrae.
Event or Problem Description
It was reported that the patient underwent an explant procedure to explant the indirect decompression (id) spacer.The patient had gotten into a golf cart accident and broken one of the legs off the spacer.Although it was not easy to get the spacer out, the physician successfully explanted the spacer and the broken leg component.The patient was reimplanted with a new spacer at the same level and an additional new spacer was added at l 3-4 lumbar vertebrae.
Additional Manufacturer Narrative
The returned spacer was analyzed and visual examination confirmed the event of the patient having a damaged spacer due to a golf cart accident.The returned implant revealed a fractured cam lobe, and tool damage to the spindle, spindle cap, and body of the implant.The damage to the implant was sufficient to prevent functional testing.A labeling review was performed and it did not reveal any anomalies as the instructions for use (ifu) states that device dislodgement, particularly if the patient experiences a traumatic event postoperatively and loosening, fatigue, deformation, breakage or disassembly of the implant, which may require another operation to remove the implant and may require another method of treatment; as well as deformation, breakage or disassembly of the implant, and spinous process fracture are among other risks associated with the procedure.The reported event of the patient having a damaged spacer due to a golf cart accident was confirmed.Visual inspection revealed a fractured cam lobe, and tool damage to the spindle, spindle cap and body of the implant.The damage to the implant was sufficient to prevent functional testing.However, a labelling review found that the reported event is a known risk associated with the use of lumbar spine implants and associated instruments.
Event or Problem Description
It was reported that the patient underwent an explant procedure to explant the indirect decompression (id) spacer.The patient had gotten into a golf cart accident and broken one of the legs off the spacer.Although it was not easy to get the spacer out, the physician successfully explanted the spacer and the broken leg component.The patient was reimplanted with a new spacer at the same level and an additional new spacer was added at l 3-4 lumbar vertebrae.

• Brand Name: SUPERION INTERSPINOUS SPACER
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): VERTIFLEX INC; 2714 loker ave west; carlsbad CA 92010
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 17819820
• Report Number: 3006630150-2023-05824
• Device Sequence Number: 17673312
• Product Code: NQO
• UDI-Device Identifier: 00884662000246
• UDI-Public: 00884662000246
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P140004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/30/2023
• Device Model Number: 100-9810
• Device Catalogue Number: 100-9810
• Device Lot Number: 800076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 10/09/2023; 11/07/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/20/2023; 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female