MAUDE Adverse Event Report: RELIANCE MEDICAL SYSTEMS RELIANCE CERVICAL IBF-S SYSTEM; CERVICAL IBF-S, SCREW, DRILLING VARIABLE, 4.0, 14MM

Model Number	2-S40-DV14
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Dysphasia (2195)
Type of Reportable Event	Malfunction
Event or Problem Description
Cervical ibf-s, screw, drilling variable, 4.0, 14mm is part of the reliance cervical ibf-s system.Reliance medical systems (rms) was made aware of the complaint wednesday, (b)(6) 2018 via phone call to rms account manager (b)(4) from field rep.(b)(4).Implantation of the device was performed (b)(6) 2018 by dr.(b)(46 at (b)(6).Patient went to three month check up with dr.(b)(6), while there the patient reported to the physician that he was experiencing dysphasia.X-rays were taken and it was discovered one of the screws had begun to back out.Revision procedure was performed (b)(6) 2018 by dr.(b)(6) to remove the screw that had begun to back out.Engineering manager (b)(4) at rms discussed the revision procedure with dr.(b)(6).(b)(4) stated, "the surgeon said that, although the abundance of tissue growth around the implant limited his view, he did not notice any discernible breakage of the ibf peek implant.He felt the fusion around the implant was mature enough to retain the peek implant without further reinforcement via bone screws.Therefore, only the screw that backed out of the implant was removed.".

• Brand Name: RELIANCE CERVICAL IBF-S SYSTEM
• Common Device Name: CERVICAL IBF-S, SCREW, DRILLING VARIABLE, 4.0, 14MM
• Manufacturer (Section D): RELIANCE MEDICAL SYSTEMS; 545 west 500 south, ste 100; bountiful UT 84010
• MDR Report Key: 7993258
• Report Number: 3006088942-2018-00001
• Device Sequence Number: 11206137
• Product Code: OVE
• UDI-Device Identifier: 00842566102107
• UDI-Public: 00842566102107
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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: Health Professional
• Device Model Number: 2-S40-DV14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/22/2018
• 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