MAUDE Adverse Event Report: NOBEL BIOCARE AB NOBELPARALLEL CC RP 4.3X15MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number 37975

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Date 06/11/2019

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

Customer selected the wrong size.

• Brand Name: NOBELPARALLEL CC RP 4.3X15MM
• 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: 9116574
• MDR Text Key: 161920404
• Report Number: 9611993-2019-16538
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 7332747091540
• UDI-Public: (01)7332747091540(10)12118197(17)230816
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K073142
• 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: 08/27/2019

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: 08/16/2023
• Device Catalogue Number: 37975
• Device Lot Number: 12118197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2018
• 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: 34 YR