MAUDE Adverse Event Report: HAGER & MEISINGER GMBH OCTAGON BONE LEVEL IMPL. BLT 4.1X10MM; DENTAL IMPLANT

Model Number	3624002DU0ACE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Implant fall into vial due to customer failure.

• Brand Name: OCTAGON BONE LEVEL IMPL. BLT 4.1X10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HAGER & MEISINGER GMBH; hansemannstr. 10; neuss, nordrhein-westfalen 41468 ; GM 41468
• MDR Report Key: 12518891
• Report Number: 8010516-2021-00049
• Device Sequence Number: 5146064
• Product Code: DZE
• UDI-Device Identifier: E0HM240021
• UDI-Public: +E0HM240021/$C03207/14D20260228S
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

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 Expiration Date: 02/28/2026
• Device Model Number: 3624002DU0ACE
• Device Catalogue Number: 24002
• Device Lot Number: C03207
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2021
• 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: Other