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

Catalog Number	753708
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's identifier, age, sex, weight, date of event, other relevant history, including preexisting medical conditions, implant date and explant date were not provided.If the requested information becomes available, a supplementary report will be submitted.Device evaluation results are not available, since the product is not returned.If the product returns analysis will be completed and a supplemental report will be submitted.(b)(4).
Event or Problem Description
Per (b)(4), during laboratory procedure, patient experienced loss or failure of implant to integrate.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated d4 for catalog # and unique identifier (udi) #, d9 for device return 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, h3 for device evaluation status and h6 method, result and conclusion codes.Device received is different from the part that was indicated on the initial 3500a report.Lot number and manufacture/expiration dates previously submitted do not apply.Lot number information is unknown.

• 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
• Manufacturer Contact: karen manalili ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8057785914
• MDR Report Key: 12370432
• Report Number: 3001617766-2021-05051
• Device Sequence Number: 1206593
• Product Code: DZE
• UDI-Device Identifier: 10841307103639
• UDI-Public: 10841307103639
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K090234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/27/2023
• Device Catalogue Number: 753708
• Device Lot Number: 128804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 11/06/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown