MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACT LEGACY2 SBM IMPLANT 4.7DX11L 4.5MMD PLAT; ENDOSSEOUS DENTAL IMPLANT

Catalog Number 824711

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2024

Event Type  Injury  

Event Description

Primary stability couldn¿t be achieved.

• Brand Name: LEGACY2 SBM IMPLANT 4.7DX11L 4.5MMD PLAT
• Type of Device: 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: 18999861
• MDR Text Key: 338878226
• Report Number: 3001617766-2024-006368
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307101383
• UDI-Public: (01)10841307101383(10)15004273(17)280301
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 824711
• Device Lot Number: 15004273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 130 KG