MAUDE Adverse Event Report: RELIANCE MEDICAL SYSTEMS RMS PEDICLE SCREW SYSTEM; 6.5MM X 50MM POLYAXIAL SCREW, TI

Model Number	6-65-050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Event or Problem Description
Reliance 6.5mm x 50mm polyaxial screw, ti, is part of the rms pedicle screw system.Reliance medical systems was made aware of the two broken screws, september 24th, 2019 via email from physician.Implantation of devices was performed (b)(6) 2018 by dr.(b)(6) at (b)(6) medical center.Dr (b)(6) discovered the broken screws during screw removal on (b)(6) 2019.Physician reported there was no injury to the patient.Screw heads were removed and sent to pathology and the embedded screw shaft was left in the bone per physician.It is unknown when or how the screws broke.

• Brand Name: RMS PEDICLE SCREW SYSTEM
• Common Device Name: 6.5MM X 50MM POLYAXIAL SCREW, TI
• Manufacturer (Section D): RELIANCE MEDICAL SYSTEMS; 545 west 500 south, ste 100; bountiful UT 84010
• MDR Report Key: 9210041
• Report Number: 3006088942-2019-00001
• Device Sequence Number: 2450813
• Product Code: NKB
• UDI-Device Identifier: 00842566105702
• UDI-Public: 00842566105702
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/11/2019

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: 6-65-050
• Device Lot Number: CT14G007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR