MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELPARALLEL CC RP 4.3X13MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number 37974

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 10/11/2023

Event Type  malfunction  

Event Description

The implant malfunctioned due to chip wrapped around cover screw threads.The malfunction did not cause or contribute to a death or serious injury.

• Brand Name: NOBELPARALLEL CC RP 4.3X13MM
• Type of Device: 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: 18232266
• MDR Text Key: 329289996
• Report Number: 9611993-2023-123641
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 07332747161298
• UDI-Public: (01)07332747161298(10)12220302(17)280318
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• 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
• Device Operator: Health Professional
• Device Catalogue Number: 37974
• Device Lot Number: 12220302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention