MAUDE Adverse Event Report: BIOHORIZONS BIOHORIZON HD IMPLANT LEVEL RATCHET DRIVER; IMPLANT LEVEL DRIVER

Model Number	TYGIDR
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The unidentified patients clinician performed an implant surgical procedure using a ratchet implant level driver.During the surgical event, the patient swallowed the implant level driver.

• Brand Name: BIOHORIZON HD IMPLANT LEVEL RATCHET DRIVER
• Common Device Name: IMPLANT LEVEL DRIVER
• Manufacturer (Section D): BIOHORIZONS; 2300 riverchase center; birmingham AL 35244
• MDR Report Key: 7311181
• Report Number: 1060818-2018-00001
• Device Sequence Number: 1801691
• Product Code: NDP
• UDI-Device Identifier: 00847236011086
• UDI-Public: 00847236011086
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/13/2018

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: Dentist
• Device Model Number: TYGIDR
• Device Catalogue Number: TYGIDR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention