MAUDE Adverse Event Report: BIOHORIZONS INC. BIOHORIZONS INC.; DENTAL IMPLANT

Model Number	TSK4000
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer stated that the entire tsk4000, unk lot is rusted.The customer has been advised to send the kit back for replacement.Unable to confirm which kit has customer has multiple in their sales history.

• Brand Name: BIOHORIZONS INC.
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOHORIZONS INC.; 2300 riverchase center; birmingham AL 35244
• Manufacturer (Section G): BIOHORIZONS INC.; 2300 riverchase center; birmingham AL 35244
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, AL 35244
• MDR Report Key: 19494375
• Report Number: 1060818-2024-07525
• Device Sequence Number: 20972062
• Product Code: DZE
• UDI-Device Identifier: 00847236011161
• UDI-Public: 00847236011161
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TSK4000
• Device Catalogue Number: TSK4000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 06/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown