MAUDE Adverse Event Report: NOBEL BIOCARE USA INC NOBELREPLACE CC RP 4.3X13MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	36708
Medical Device Problem Code	Appropriate Term/Code Not Available (3191)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The user indicated a malfunction of the device during placement, however based on the available information the exact issue could not be identified.The malfunction did not cause or contribute to a death or serious injury.

• Brand Name: NOBELREPLACE CC RP 4.3X13MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE USA INC; 22725 savi ranch; yorba linda CA 92887 4609
• MDR Report Key: 12556877
• Report Number: 2027971-2021-115595
• Device Sequence Number: 904501
• Product Code: DZE
• UDI-Device Identifier: 7332747035698
• UDI-Public: (01)7332747035698(10)13111021(17)2026030
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K073142
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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 Expiration Date: 03/08/2026
• Device Catalogue Number: 36708
• Device Lot Number: 13111021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2021
• 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: Required Intervention