MAUDE Adverse Event Report: RELIANCE MEDICAL SYSTEMS RELIANCE SPINAL SCREW SYSTEM; RELIANCE PSS TI ROD, STR, 6.0X400

Model Number	6-02-400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/01/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Patient reported having a titanium rod break in early (b)(6) 2016.Reliance pss ti rod, straight, 6.0x400mm is part of the rms pedicle screw system.Reliance medical systems was made aware of the broken rod (b)(4) 2017 via email.Implantation of device was performed (b)(6) 2016 by dr.(b)(6) at (b)(6) for an unstable l1 fracture.The patient reported swimming and aqua fit session three times a week and being able to return to playing golf after the original procedure prior to the rod breaking.Patient reported he was standing at his kitchen counter brewing tea.Patient reached over to his right and heard a loud "cracking noise" combined with sharp back pain.Patient went to physician providing his post-operative care, dr.(b)(6), chief neurosurgeon at (b)(6) for x-rays.After reviewing the x-rays, dr.(b)(6) did not feel a revision surgery was indicated since the back had already 6 months to heal and the second rod was still in place.Dr.(b)(6) wanted to review again after 5-6 months, which revealed the second rod still in place without break and the broken rod without shift or movement.A final visit is scheduled in 12 months.

• Brand Name: RELIANCE SPINAL SCREW SYSTEM
• Common Device Name: RELIANCE PSS TI ROD, STR, 6.0X400
• Manufacturer (Section D): RELIANCE MEDICAL SYSTEMS; 545 west 500 south, ste 100; bountiful UT 84010
• MDR Report Key: 6675497
• Report Number: 3006088942-2017-00001
• Device Sequence Number: 45502
• Product Code: MNH
• UDI-Device Identifier: 00842566105108
• UDI-Public: 00842566105108
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2017

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: Physician
• Device Model Number: 6-02-400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR