MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACT SWISHPLUS 4.1MMDX10MML SBM BLASTED; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	924110
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary stability couldn¿t be achieved.

• Brand Name: SWISHPLUS 4.1MMDX10MML SBM BLASTED
• 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: sergio alvarado ; 3050 east hillcrest drive; thousand oaks 91362 ; 805778
• MDR Report Key: 18321113
• Report Number: 3001617766-2023-005318
• Device Sequence Number: 12532959
• Product Code: DZE
• UDI-Device Identifier: 10841307106142
• UDI-Public: (01)10841307106142(10)15007282(17)280606
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial

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: 924110
• Device Lot Number: 15007282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2023
• 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: 208 KG