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

Model Number 1-1001-6555

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure of Implant (1924)

Event Date 08/24/2023

Event Type  malfunction  

Event Description

Implanting physician reported a construct failure at the l5-s1 level via screw fracture.The failure occured rought 3 year post implantion and has been accredited to issue related to non-union of bone.

• Brand Name: BLACK DIAMOND PEDICLE SCREW
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): OSSEUS FUSION SYSTEM, 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 greenvile ave.; suite 200; dallas, TX 75206 ; 8883305960
• MDR Report Key: 17804216
• MDR Text Key: 324114134
• Report Number: 3010531060-2023-23002
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1-1001-6555
• Device Catalogue Number: 1-1001-6555
• Device Lot Number: 2197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White