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

Model Number 6-65-C45

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

Reliance 6.5x45mm cannulated polyaxial screw, ti, is part of the rms pedicle screw system.Reliance medical systems was made aware of the broken screw on september 9, 2020 via email from field rep (b)(6).Implantation of device was performed (b)(6) 2019 by (b)(6) at (b)(6).(b)(6) performed a revision surgery on (b)(6) 2020 at the same hospital.Physician reported there was no 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
• Type of Device: 6.5MM X 50MM REDUCTION 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: 10638598
• MDR Text Key: 214382176
• Report Number: 3006088942-2020-00001
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00842566105962
• UDI-Public: 00842566105962
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6-65-C45
• Device Catalogue Number: 6-65-R50
• Device Lot Number: CT17L058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 38 YR