MAUDE Adverse Event Report: NOBEL BIOCARE AB BRÅNEMARK SYSTEM MK III RP 3.75X13MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	28887
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to an osseointegration problem.

• Brand Name: BRÅNEMARK SYSTEM MK III RP 3.75X13MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• Manufacturer (Section G): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• Manufacturer Contact: gayco meel ; popeweg 72; venlo 5928 -SC ; NL 5928 SC ; 623202508
• MDR Report Key: 15262069
• Report Number: 9611993-2022-088060
• Device Sequence Number: 5746128
• Product Code: DZE
• UDI-Device Identifier: 07332747159387
• UDI-Public: (01)07332747159387(10)12141355(17)240815
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K925765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial

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: 08/15/2024
• Device Model Number: 28887
• Device Catalogue Number: 28887
• Device Lot Number: 12141355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2019
• 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