MAUDE Adverse Event Report: RELIANCE MEDICAL SYSTEMS RELIANCE PCT 3.5 SYS; PCT SET SCREW, TI

Model Number	5-00-001
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 pct set screw, ti, is part of the rms pct 3.5 system.Reliance medical systems was made aware of the loose set screw, (b)(6) 2022 via text message from dr.(b)(6).Implantation of device was performed in 2022 by dr.(b)(6).Dr (b)(6) discovered the a set screw had come off a pct screw, at c2, about 1 month post-op.Physician reported there was no harm or injury to the patient, and "he is doing very well clinically so no plans to removing/revising." it is unknown when or how the set screw came off the pct screw.Dr (b)(6) reported "patient doesn't recall any trauma or anything.".

• Brand Name: RELIANCE PCT 3.5 SYS
• Common Device Name: PCT SET 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 ; 8012943280
• MDR Report Key: 14640596
• Report Number: 3006088942-2022-00001
• Device Sequence Number: 20257372
• Product Code: KWP
• UDI-Device Identifier: 00842566104170
• UDI-Public: 00842566104170
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2022

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: 5-00-001
• Device Catalogue Number: 5-00-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2022
• 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: Male