MAUDE Adverse Event Report: SPINAL RESOURCES, INC. SWEDGE PEDICLE SCREW FIXATION SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number LC-03

Device Problems Difficult to Remove (1528); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 05/11/2020

Event Type  malfunction  

Event Description

Removal of previous implant hardware from previous surgery.Locking caps intended to be removable but were unable to be removed led to additional surgical maneuvers.

• Brand Name: SWEDGE PEDICLE SCREW FIXATION SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINAL RESOURCES, INC.; 5975 north federal highway suite 250; fort lauderdale FL 33308
• MDR Report Key: 10086623
• MDR Text Key: 191976708
• Report Number: 10086623
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: LC-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2020
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21170 DA