MAUDE Adverse Event Report: RELIANCE MEDICAL SYSTEMS RMS SPINAL SCREW SYSTEM; SET SCREW, TI

Model Number	3-00-001
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Reliance set screw, ti, is part of the rms spinal screw system.Reliance medical systems was made aware of the loose set screw, (b)(6) 2022 by field rep john hunt.Implantation of device was performed (b)(6) 2022 by dr.Esce.Dr esce discovered a set screw had come off a pedicle screw during a post op.It is unknown when or how the set screw came off the pedicle screw.

• Brand Name: RMS SPINAL SCREW SYSTEM
• Common Device Name: SET SCREW, TI
• Manufacturer (Section D): RELIANCE MEDICAL SYSTEMS; 545 west 500 south, ste 100; bountiful UT 84010
• MDR Report Key: 14671824
• Report Number: 3006088942-2022-00002
• Device Sequence Number: 4956845
• Product Code: NKB
• UDI-Device Identifier: 00842566102206
• UDI-Public: 00842566102206
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K152131
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2022

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: 3-00-001
• Device Catalogue Number: 3-00-001
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Female