MAUDE Adverse Event Report: NOBEL BIOCARE AB BRANEMARK SYSTEM MK III RP 3.75X11.5MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	28886
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).Revoked asr exemption number e1997036 'report late due to asr to individual reporting transition'.
Event or Problem Description
Implant failed due to failure to osseointegrate.

• Brand Name: BRANEMARK SYSTEM MK III RP 3.75X11.5MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovgen 2; karlskoga, SE-69 151; SW SE-69151
• MDR Report Key: 9063985
• Report Number: 9611993-2019-09746
• Device Sequence Number: 14246396
• Product Code: DZE
• UDI-Device Identifier: 07332747004700
• UDI-Public: (01)07332747004700(10)12084184(17)220312
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/19/2019

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: 03/12/2022
• Device Model Number: 28886
• Device Catalogue Number: 28886
• Device Lot Number: 12084184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 09/15/2019
• 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
• Patient Age: 52 YR