MAUDE Adverse Event Report: OSSEUS FUSION SYSTEMS, LLC. BLACK DIAMOND PEDICLE SCREW

Model Number 1-1001-6545

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 04/09/2021

Event Type  malfunction  

Event Description

Tulip of pedicle screw seperated from bone screw during procedure.Screw was removed and case went forward as planned.

• Brand Name: BLACK DIAMOND PEDICLE SCREW
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): OSSEUS FUSION SYSTEMS, LLC.; 1931 greenville ave.; suite 200; dallas TX 75206
• Manufacturer (Section G): OSSEUS FUSION SYSTEMS, LLC.; 1931 greenville ave.; suite 200; dallas TX 75206
• Manufacturer Contact: jonathan rosen ; 1931 greenville ave; suite 200; dallas, TX 75206 ; 8883305960
• MDR Report Key: 15176154
• MDR Text Key: 304698441
• Report Number: 3010531060-2021-00003
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: B0621100065450
• UDI-Public: +B0621100065450/$$7190842AD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1-1001-6545
• Device Catalogue Number: 1-1001-6545
• Device Lot Number: 190842A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White