MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELPARALLEL CC RP 4.3X10MM; ENDOSSEOUS DENTAL IMPLANT

Model Number 37972

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 06/20/2019

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).Revoked asr exemption number e1997036.'"report late due to asr to individual reporting transition"'.Nobel biocare is both the manufacturer and importer and no report from the importer to the manufacturer is needed'.

Event Description

Implant failed and removed due to broken / fractured component.

• Brand Name: NOBELPARALLEL CC RP 4.3X10MM
• Type of Device: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovgen 2; karlskoga, SE-69 151; SW SE-69151
• MDR Report Key: 9068237
• MDR Text Key: 160374392
• Report Number: 2027971-2019-21847
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 07332747091519
• UDI-Public: (01)07332747091519(10)12125074(17)231206
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/15/2019,07/01/2019

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: 12/06/2023
• Device Model Number: 37972
• Device Catalogue Number: 37972
• Device Lot Number: 12125074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2019
• Distributor Facility Aware Date: 07/01/2019
• Event Location: Outpatient Treatment Facility
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR