MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACT SCREWINDIRECT SBM, 3.7D X 10L; ENDOSSEOUS DENTAL IMPLANT

Catalog Number 403710

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Date 10/26/2023

Event Type  Injury  

Event Description

Other product deficiencies and technical.

• Brand Name: SCREWINDIRECT SBM, 3.7D X 10L
• 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: 18412588
• MDR Text Key: 331541548
• Report Number: 3001617766-2023-005456
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307104766
• UDI-Public: (01)10841307104766(10)15009204(17)280803
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• 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
• Device Operator: Health Professional
• Device Catalogue Number: 403710
• Device Lot Number: 15009204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2023
• 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: 67 YR
• Patient Sex: Male