MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELSPEEDY REPLACE RP 4X13MM; ENDOSSEOUS DENTAL IMPLANT

Model Number 32202

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 08/23/2010

Event Type  Injury  

Event Description

Implant failed due to part/interface does not fit/align.

• Brand Name: NOBELSPEEDY REPLACE RP 4X13MM
• 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: 16692568
• MDR Text Key: 312810537
• Report Number: 9611993-2023-056347
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 07332747001716
• UDI-Public: (01)07332747001716(10)727483(17)150426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2015
• Device Model Number: 32202
• Device Catalogue Number: 32202
• Device Lot Number: 727483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/04/2010
• 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
• Patient Age: 67 YR
• Patient Sex: Male