MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLANT 6.0MMD X 11.5MML SBM; DENTAL IMPLANT

Model Number 606011

Device Problem Device-Device Incompatibility (2919)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 11/13/2017

Event Type  malfunction  

Event Description

Per (b)(4) complainant reported once implant placed could not unscrew carrier off.Lot number unknown as not reported.

Manufacturer Narrative

Follow-up submitted to report device evaluation.

• Brand Name: REPLANT 6.0MMD X 11.5MML SBM
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 7324356
• MDR Text Key: 102081439
• Report Number: 3001617766-2018-00010
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307104155
• UDI-Public: 10841307104155
• Combination Product (y/n): N
• PMA/PMN Number: K061319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

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: Dentist
• Device Model Number: 606011
• Device Catalogue Number: 606011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 03/08/2018
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 08/31/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR