MAUDE Adverse Event Report: RELIANCE MEDICAL SYSTEMS, LLC; ORTHOSIS, SPINAL PEDICLE FIXATION

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/18/2019

Event Type  malfunction  

Event Description

Tip of straight pedicle probe broke off in patient bone, approximately 3mm in diameter and approximately 20mm in length was left in the patient bone.Tip left in patient per surgeon.

• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): RELIANCE MEDICAL SYSTEMS, LLC; 545 west 500 south ste. 100; bountiful UT 84010
• MDR Report Key: 9543049
• MDR Text Key: 173465317
• Report Number: 9543049
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20440 DA