MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC REACTIVE IMPLANT; DENTAL IMPLANT

Catalog Number	753716
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant date and explant dates were not provided.If the requested information becomes available, a supplementary report will be submitted.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.
Event or Problem Description
Per complaint (b)(4), during clinical procedure, broken/ fractured component was observed.
Additional Manufacturer Narrative
Follow-up submitted for additional information.Updated section b4 for report submission date, g1 for follow-up report submitter, g3 for awareness date and g6 for report type and follow-up number.Updated h2 for follow-up type.Date of implant &expalnt are unknown.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.

• Brand Name: REACTIVE IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 12540126
• Report Number: 3001617766-2021-05648
• Device Sequence Number: 14478922
• Product Code: DZE
• UDI-Device Identifier: 10841307103622
• UDI-Public: 10841307103622
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K080713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2022
• Device Catalogue Number: 753716
• Device Lot Number: 99889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 10/04/2021; 10/28/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/07/2021; 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 113