MAUDE Adverse Event Report: NOBEL BIOCARE AB ZYGOMA IMPLANT RP 45MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	28866
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The implant malfunctioned due to part/interface does not fit/align.The malfunction did not cause or contribute to a death or serious injury.

• Brand Name: ZYGOMA IMPLANT RP 45MM
• 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: 18358742
• Report Number: 9611993-2023-129372
• Device Sequence Number: 20860266
• Product Code: DZE
• UDI-Device Identifier: 07332747159332
• UDI-Public: (01)07332747159332(10)12206678(17)270811
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 28866
• Device Lot Number: 12206678
• Was Device Available for Evaluation?: No
• 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: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2022
• 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 Age: 76 YR
• Patient Sex: Female