MAUDE Adverse Event Report: OSSEUS FUSION SYSTEMS, LLC. BLACK DIAMOND PEDICLE SCREW SYSTEM; PARALLEL ROD CONNECTOR

Model Number 1006-8000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Malunion of Bone (4529)

Event Date 01/04/2022

Event Type  malfunction  

Event Description

Patient with pre-existing paraplegia and other severe pathologies was examined 120 days post op.Follow up imaging depicted that titanium rod had migrated out of black diamond parallel rod connector.Revision surgery was performed and all screws in construct were replaced with black diamond to ensure system performance, as well as a quad rod construct to resist anatomical forces associated with the presented pathology.

• Brand Name: BLACK DIAMOND PEDICLE SCREW SYSTEM
• Type of Device: PARALLEL ROD CONNECTOR
• Manufacturer (Section D): OSSEUS FUSION SYSTEMS, LLC.; 1931 greenville avenue; suite 200; dallas TX 75206
• Manufacturer (Section G): OSSEUS FUSION SYSTEMS, LLC.; 1931 greenville avenue; suite 200; dallas TX 75206
• Manufacturer Contact: jonathan rosen ; 1931 greenville avenue; suite 200; dallas, TX 75206 ; 8883305960
• MDR Report Key: 15106412
• MDR Text Key: 304714181
• Report Number: 3010531060-2022-00001
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: B06210068000
• UDI-Public: +B06210068000/$$7200978B
• 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: Patient Monitoring
• Type of Report: Initial
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1006-8000
• Device Catalogue Number: 1006-8000
• Device Lot Number: 200975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White