MAUDE Adverse Event Report: NOBEL BIOCARE AB BRANEMARK SYSTEM MK III TIU RP 3.75X10MM; ENDOSSEOUS DENTAL IMPLANT

Model Number 28913

Device Problems Break (1069); Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 05/29/2019

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).Revoked asr exemption number e1997036.'"report late due to asr to individual reporting transition"'.

Event Description

Implant failed and removed due to broken / fractured component.

• Brand Name: BRANEMARK SYSTEM MK III TIU RP 3.75X10MM
• Type of Device: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovgen 2; karlskoga, SE-69 151; SW SE-69151
• Manufacturer (Section G): NOBEL BIOCARE AB; dimbovgen 2; karlskoga, SE-69 151; SW SE-69151
• Manufacturer Contact: pramod gouda ; kozakkenberg 4; 5951 dl belfeld, ; NL
• MDR Report Key: 9063146
• MDR Text Key: 160318074
• Report Number: 9611993-2019-15102
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 07332747001174
• UDI-Public: (01)07332747001174(10)12051277(17)200926
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K022562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/20/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2020
• Device Model Number: 28913
• Device Catalogue Number: 28913
• Device Lot Number: 12051277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 09/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2015
• 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: 71 YR