MAUDE Adverse Event Report: SPINECRAFT VELOX ANTERIOR CERVICAL PLATE SYSTEM; SCREW

Model Number	VVS2-4012
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the device was not returned for evaluation to spinecraft and was discarded by the hospital, the exact lot number of the device used could not be retrieved.However, based on the 5 lot numbers (110530, 110532, 113669, 187213 and 91156) manufactured of the same screw size that were in this specific kit (one of which was used in this surgery), the review of the device history records was performed for applicable material, manufacturing processes, design specifications and inspection records.No deviations or discrepancies were found.Furthermore, the usage history review for these 5 lots showed that a total of 367 screws out of the 909 manufactured from these lots have been used in different surgeries without any reported issues.Also, a general review of the usage history of velox system screws and complaint trend analysis showed that thousands of these screws have been used in surgeries since the launch of the system in 2014 and no similar issues have been reported to date.Based on the pre-operative (before the revision surgery) x-ray images provided, the screw back out was confirmed, however, no conclusions could be made.The x-ray image also showed that the plate ring was intact and had no signs of dislodgement.Since screw back out is a known risk, numerous testing were performed during system development to eliminate this failure mode and all necessary verification / validation activities were completed before the release of velox system to confirm that this failure mode will not occur during clinical use.Based on the above information and absence of post-operative x-rays from the original surgery, no definitive root cause can be determined as no issue has been identified with the design, manufacturing or release of any of the screw lots which may have been used in surgery that could have contributed to problem reported.It can be presumed however that the screw back out occurred due to the fact that the screw may not have been fully inserted into the plate locking ring causing incomplete locking of the screw.This incomplete insertion may have been due to the following known and identified risks: insufficient torque application, extreme angulation of screw beyond what the plate design allows or a non-centered drilled hole if the drill guide was not used.
Event or Problem Description
Approximately 3.5 months post-operatively after a periodic patient follow-up, the x-ray images revealed that one (1) velox screw had backed out by a few millimeters from the plate.There were no clinical symptoms reported by the patient; however, the surgeon decided to perform a revision surgery to replace this screw.When the surgery was performed, the surgeon confirmed that the plate ring holding the screw in question was intact and the surgery was completed as intended with no patient complications reported.

• Brand Name: VELOX ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: SCREW
• Manufacturer (Section D): SPINECRAFT; 777 oakmont lane, suite # 200; westmont,
• MDR Report Key: 10182158
• Report Number: 3004717358-2020-00002
• Device Sequence Number: 2924444
• Product Code: KWQ
• UDI-Device Identifier: 00193082001086
• UDI-Public: 00193082001086
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2020

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: Health Professional
• Device Model Number: VVS2-4012
• Device Catalogue Number: VVS2-4012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 06/22/2020
• 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
• Patient Age: 38 YR