MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACT SIMPLY ICONIC SBM IMP 4.7X3.4 PLAT 08MML; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	674708RP
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
"describe event or problem" corrected to "lack of primary stability"."relevant test/laboratory data" corrected to "part not returned".
Event or Problem Description
Lack of stability during placement.
Event or Problem Description
Part not returned.

• Brand Name: SIMPLY ICONIC SBM IMP 4.7X3.4 PLAT 08MML
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACT; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT SYBRON MANUFACT; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: anitha mechery ; 3050 east hillcrest drive; thousand oaks 91362 ; 8057785975
• MDR Report Key: 24913424
• Report Number: 3001617766-2026-006538
• Device Sequence Number: 9928558
• Product Code: DZE
• UDI-Device Identifier: 10841307125174
• UDI-Public: (01)10841307125174(10)15027109(17)300610
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup

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 Catalogue Number: 674708RP
• Device Lot Number: 15027109
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2025
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 200 KG