MAUDE Adverse Event Report: HAGER & MEISINGER GMBH OKTAGON BLT RC 4.8X8MM; DENTAL IMPLANT

Model Number	24005DU0000
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant was removed, no further information were given.A different implant 3.3x8mm (ref 23001 lot: b41959) was seated.

• Brand Name: OKTAGON BLT RC 4.8X8MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HAGER & MEISINGER GMBH; hansemannstr. 10; neuss, nordrhein-westfalen 41468 ; GM 41468
• MDR Report Key: 11383335
• Report Number: 8010516-2021-00003
• Device Sequence Number: 19843098
• Product Code: DZE
• UDI-Device Identifier: E0HM240051
• UDI-Public: +E0HM240051/$B23491/14D20221231S
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K180360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 01/13/2021

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: 12/31/2022
• Device Model Number: 24005DU0000
• Device Lot Number: B23491
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2021
• 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
• Patient Age: 89 YR