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

Catalog Number	943310
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's identifier, age, sex, weight, explant date were not provided.If the requested information becomes available, a supplementary report will be submitted.The implant failure modes, failure/ loss of osseo-integration and lack of primary stability are not product related and rather are attributed to patient contraindications, conditions, or clinician error in surgical protocol.No product investigation or corrective actions required.Complaints will continue to be trended.
Event or Problem Description
Per complaint (b)(4), after clinical procedure, patient experienced failure of implant to osseointegrate.
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.Updated section a1, a2, a3, a4 and b7 for patient identifier, age, sex, weight and oral hygiene.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.

• Brand Name: SWISHACTIVE 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: 14250070
• Report Number: 3001617766-2022-02181
• Device Sequence Number: 4774254
• Product Code: DZE
• UDI-Device Identifier: 10841307106609
• UDI-Public: 10841307106609
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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: 06/23/2026
• Device Catalogue Number: 943310
• Device Lot Number: 188719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2021
• 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 Age: 61 YR
• Patient Sex: Female
• Patient Weight: 57 KG