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

Model Number 084814

Device Problems Mechanical Problem (1384); Failure to Osseointegrate (1863); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 01/10/2018

Event Type  malfunction  

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 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
• Type of Device: ANTERIOR CERVICAL PLATE SCREW
• Manufacturer (Section D): SPINAL ELEMENTS; 1755 west oak parkway; marietta GA 30062
• Manufacturer Contact: tiffiney teo ; 1755 west oak parkway; marietta, GA 30062 ; 7705755274
• MDR Report Key: 7610539
• MDR Text Key: 111858496
• Report Number: 1067095-2018-00003
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00840916115517
• UDI-Public: 00840916115517
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 084814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention