MAUDE Adverse Event Report: RELIANCE MEDICAL SYSTEMS RELIANCE ANTERIOR CERVICAL PLATE SYSTEM; RACP COVER PLATE ASSEMBLY

Model Number	4-01-001
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Event or Problem Description
Reliance cover plate assembly is part of the reliance anterior cervical plate system.Reliance medical systems was made aware of the complaint tuesday, (b)(6) 2017 via text message from field rep.(b)(6).Implantation of device was performed (b)(6) 2017 by dr.(b)(6) at (b)(6) hospital.Patient fell at home two months before revision surgery.Patient didn't come in to get his neck checked out until a week before the revision surgery.Patient reported having pain in neck.Senior engineer at reliance medical systems reviewed the returned cover plate assembly.He stated, "when the cervical bone screws backed out of the vertebral body, they pushed the cover plate away from the cervical plate.This bent the cover plate and damaged the locking screw for the cover plate.However, both the locking screw and the cover plate remained intact, and the cervical bone screws remained partially embedded in the vertebral body." revision surgery was performed by the same physician on (b)(6) 2017 at the same hospital.

• Brand Name: RELIANCE ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: RACP COVER PLATE ASSEMBLY
• Manufacturer (Section D): RELIANCE MEDICAL SYSTEMS; 545 west 500 south, ste 100; bountiful UT 84010
• MDR Report Key: 7207258
• Report Number: 3006088942-2017-00003
• Device Sequence Number: 19061874
• Product Code: KWQ
• UDI-Device Identifier: 00842566102275
• UDI-Public: 00842566102275
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K140742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 4-01-001
• Device Lot Number: CT14K080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR