MAUDE Adverse Event Report: SPINAL ELEMENTS REGENT; ANTERIOR CERVICAL PLATE SCREW

Model Number	084814
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Osseointegrate (1863); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No radiographs or images were provided, confirming the event.No product was returned, no product information was given, and no further evaluation of the product can be completed at this time.Patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, patient compliance with post-operative care instructions, or if the patient sustained a fall/impact of any sort are all unknown.The failure could not be confirmed and the root cause cannot be determined.Review of labeling notes; contraindications: any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis.Insufficient quality or quantity of bone which would inhibit rigid device fixation.Adverse effects loosening of the implant.Screw back-out possibly leading to esophageal erosion implant loosing or reoperation for device removal.
Event or Problem Description
Reportedly the initial two level acdf surgery was performed on (b)(6) 2017.On (b)(6) 2018 allegedly one of the six screws backed out of the plate.Revision surgery occurred to remove and replace one screw.Hospital retained the screw.No further information provided.

• Brand Name: REGENT
• Common Device Name: ANTERIOR CERVICAL PLATE SCREW
• Manufacturer (Section D): SPINAL ELEMENTS; 1755 west oak parkway; marietta GA 30062
• MDR Report Key: 7610539
• Report Number: 1067095-2018-00003
• Device Sequence Number: 1318124
• Product Code: KWQ
• UDI-Device Identifier: 00840916115517
• UDI-Public: 00840916115517
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K101151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2018

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: Physician
• Device Model Number: 084814
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 06/18/2018
• 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: Required Intervention