MAUDE Adverse Event Report: VERTIFLEX, INC. SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS); INTERSPINOUS SPACER

Model Number	DRIVER
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Material Fragmentation (1261)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The report from the manufacturer's representative who was observing the clinical case indicated that the interspinous space into which the implant was being placed was "very tight," and resisted placement and deployment of the implant.The physician considered aborting the procedure for this reason, but eventually elected to try to proceed.In attempting to place and deploy (open) the implant despite significant resistance from the "very tight" anatomy, the representative believes that the physician exerted excessive torque to the manual driver instrument, at which time the distal tip of the driver fractured.Multiple attempts were made to retrieve the driver fragment (including suction and grasping the fragment with forceps), but the fragment was firmly embedded in the distal end of the implant.Since the implant was fully deployed and acceptably placed, and the driver fragment was so firmly attached to the implant, the physician elected to leave it in situ and close.The physician has been advised of the potential risks associated with allowing this fragment to remain in situ.
Event or Problem Description
During attempts to place a superion ids at l3/l4, the distal tip of the manual driver instrument broke off.The fragment was firmly lodged in the proximal end of the implant, and resisted the physician's efforts to extract it.As it was firmly attached to the implant, and the implant was correctly placed, the physician elected to leave it in place and close.The company representative who was observing the case reports that the interspinous space into which the implant was being placed was "very tight" such that significant resistance to implant deployment was experienced.He suggested that the physician applied excessive torque to the driver to complete implant placement, which may have exceeded the strength of the driver, resulting in the fracture of the distal tip.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS)
• Common Device Name: INTERSPINOUS SPACER
• Manufacturer (Section D): VERTIFLEX, INC.; 2714 loker avenue west; suite 100; carlsbad CA 92010
• MDR Report Key: 8029272
• Report Number: 3005882106-2018-00008
• Device Sequence Number: 1643636
• Product Code: NQO
• UDI-Device Identifier: 00884662000123
• UDI-Public: 00884662000123
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2023
• Device Model Number: DRIVER
• Device Catalogue Number: 102-9108
• Device Lot Number: 183240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/01/2018
• 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: Other