MAUDE Adverse Event Report: RELIANCE MEDICAL SYSTEMS RMS PEDICLE SCREW SYSTEM; 6.5X50MM POLYAXIAL SCREW, TI

Model Number	6-65-050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Reliance 6.5mmx50mm polyaxial screw, ti, is part of the rms pedicle screw system.Reliance medical systems was made aware of the broken screw, on (b)(6) 2021 via email from field rep (b)(6).Implantation of device was performed on (b)(6) 2017 by dr.(b)(6) at (b)(6) hospital.Dr.(b)(6) discovered the broken screw during revision on (b)(6) 2021.Physician reported there was no harm or injury to the patient.Screw head was removed and the embedded screw shaft was left in the bone per physician.It is unknown when or how the screw broke.

• Brand Name: RMS PEDICLE SCREW SYSTEM
• Common Device Name: 6.5X50MM POLYAXIAL SCREW, TI
• Manufacturer (Section D): RELIANCE MEDICAL SYSTEMS; 545 west 500 south, ste 100; bountiful UT 84010
• Manufacturer Contact: jordan hendrickson ; 545 west 500 south, ste 100; bountiful, UT 84010 ; 8012953280
• MDR Report Key: 12829163
• Report Number: 3006088942-2021-00002
• Device Sequence Number: 19811511
• 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: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

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 Catalogue Number: 6-65-050
• Device Lot Number: CT17B041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male