MAUDE Adverse Event Report: DEGEN MEDICAL HYPER-C ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY SYSTEM

Model Number 0201-4016V

Device Problems Material Protrusion/Extrusion (2979); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

One cyclops four-level cervical plate (p/n 0220-4068t, lot # 190164l25), five 14mm 4.0 variable self drilling screws (p/n 0201-4014v, lot # 190196l02b), and five 16mm 4.0 variable self drilling screws (p/n 0201-4016v, lot # 190263l01a) were returned to degen medical.The cervical plate was reviewed first.The screw lock (locking mechanism) for the bottom level had been broken below its wing body and was returned with the plate.The swaged portion of the lock below the break remained captive in the plate.The broken screw lock had significant gouging underneath both wing tips, which is the portion of the lock that covers the screw when in the locked position.This is consistent with forcible rotation of the screw lock over the top of screw heads protruding above the plate surface.Clinical insertion of variable angle bone screws within the angulation parameters described in the system surgical technique and seating the screw heads in the plate holes will minimize the prominence of the screw heads.This avoids potential damage to the screw lock from screw head interference when locking the bone screw.There was no indication from the visible condition of the plate that the screw lock was forced beyond the stops.A total of ten screws were returned.The screw that backed out of the plate and the other screw from the bottom level were identified separately from the other screws.The two screws from the bottom level showed significantly more wear than the other returned screws.This could have been caused by the lock being forced over the screws.The cervical plate and each of the cervical screws were inspected for dimensional accuracy per the applicable inspection form.All dimensions were found to be within specification.The cervical plate and each of the cervical screws were inspected for dimensional accuracy per the applicable inspection form.All dimensions were found to be within specification.The device history records for lot 190164l25 (p/n 0220-4068t), lot 190196l02b (p/n 0201-4014v), and lot 190263l01a (p/n 0201-4016v) were reviewed.All parts from the three lots met all requirements and were dimensionally within specification when inspected.There were no other discrepancies or issues noted in the dhrs.The investigation results indicate that user error is the likely root cause of this complaint/event.A combination of the stress associated with the screw lock being forcibly turned over a protruding screw and strenuous physical activity by the patient after surgery caused the screw lock to fracture and rotate to the open position.Once the screw lock was no longer covering the screw, the screw was able to back out from the plate.The patient's physical activities could also have expediated the screw backing out.Per the cyclops instructions for use, "instructions to the patient: postoperative care and the patient's willingness to follow instructions are one of the most important aspects of successful bone healing.The patient must be made aware of the limitations of the implant and follow the postoperative care regimen as instructed by his or her physician.".

Event Description

Degen medical was notified that a hyper-c anterior cervical system screw backed out of a 4-level cyclops anterior cervical system plate.The original surgery occurred on (b)(6) 2020.Radiographic images during a post-operation follow-up with the patient showed that one cervical screw backed out from the plate.A revision surgery was completed on (b)(6) 2020 to remove the existing plate and screws and to implant a new cervical plate and screws.During the removal of the original hardware as part of the revision surgery it was found that the locking mechanism, which was intended to cover the backed out screw, was in the open position.The locking mechanism had broken away from the plate.No patient harm was reported from this event.This report captures the screw.An additional report is created for the plate.

• Brand Name: HYPER-C ANTERIOR CERVICAL PLATE SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY SYSTEM
• Manufacturer (Section D): DEGEN MEDICAL; 1321-c n. cashua drive; florence SC 29501
• Manufacturer Contact: craig black ; 1321-c n. cashua drive; florence, SC 29501 ; 8772407838
• MDR Report Key: 10836227
• MDR Text Key: 232001462
• Report Number: 3010663372-2020-00002
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00842048106197
• UDI-Public: 842048106197
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0201-4016V
• Device Catalogue Number: 0201-4016V
• Device Lot Number: 190263L01A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR