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

Model Number	10MM
Medical Device Problem Codes	Fracture (1260); Patient-Device Incompatibility (2682); Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the original implant was discarded at the facility, no evaluation of the device could be performed.A second implant, which the physician attempted to place during the reoperation, reportedly broke during attempts at placement, and this implant was returned to the manufacturer.Examination confirmed that one side of the inferior cam lobe had broken off.The nature of the fracture suggests significant lateral force had been applied, such that the titanium component failed.The description of the event suggests that the patient's anatomy "was not conducive" to placement of the implant, and that the device failed after several unsuccessful attempts at placement.The physician hypothesized that this abnormal anatomy caused both implants (the original and the attempted replacement) to rotate during deployment and ultimately fracture.While we cannot be certain, it may be that an unusually thick spinous process, and/or a grossly misaligned spinous process, could have placed extreme lateral force (torsion) on the implant, causing the failure.Testing has established that the implant component which failed will endure nearly 9 n-m of torsion before failure, suggesting that the abnormal anatomy and multiple deployment attempts placed a substantial strain on the device.
Event or Problem Description
Manufacturer's case coverage representative noted that during a case performed on (b)(6), "upon removal of implant, we discovered that the inferior wing had completely sheared off.When attempting to reinsert a new superion, we discovered the patient's anatomy was not conducive to the implant.When tamping it down, it caused the implant to rotate and torque to the side which caused the wing to break off." this was interpreted by manufacturer as an intra-operative implant failure (breakage) attributable to incompatible anatomy, but because there were no adverse patient sequelae, it was not a reportable event.Subsequent information received from the responsible sales representative on (b)(6), however, established that the (b)(6), procedure was, in fact, a reoperation scheduled to remove and replace an implant originally placed on (b)(6), which post-operative x-rays suggested to the treating physician was "not correctly placed." it was this implant that was found, during the (b)(6) reoperation, to have broken.The fact that reoperation was required to correct the original treatment now warrants reporting.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• Common Device Name: INTERSPINOUS SPACER
• Manufacturer (Section D): VERTIFLEX, INC.; 2714 loker avenue west; suite 100; carlsbad CA 92010
• MDR Report Key: 6863379
• Report Number: 3005882106-2017-00004
• Device Sequence Number: 1365066
• Product Code: NQO
• UDI-Device Identifier: 00884662000246
• UDI-Public: 00884662000246
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2017

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: Physician
• Device Model Number: 10MM
• Device Catalogue Number: 100-9810
• Device Lot Number: 091636R1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 09/13/2017
• 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
• Patient Age: 80 YR
• Patient Weight: 95