MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SIMPLYLEGACY2 IMPLANT 5.2MMD X 6MML SBM; DENTAL IMPLANT

Model Number 825206U

Device Problem Device-Device Incompatibility (2919)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 01/15/2018

Event Type  Injury  

Event Description

Per complaint no.(b)(4), complainant reported that during hand tightening with ratchet during implant placement, driver became stuck in implant and implant came out of osteotomy.Contraindications include smoking and the patient was (b)(6) years of age.Follow-up report 3001617766-2018-00045 will be submitted for the potentially malfunctioning hex tool reported in this incident in complaint no.(b)(4).More information on the reason for the malfunction will be available once implant direct receives the returned parts and completes a qa inspection.

Event Description

Per complaint no.(b)(4), complainant reported that during hand tightening with ratchet during implant placement, driver became stuck in implant and implant came out of osteotomy.

• Brand Name: SIMPLYLEGACY2 IMPLANT 5.2MMD X 6MML SBM
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: lia meshwork ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 7339259
• MDR Text Key: 102451941
• Report Number: 3001617766-2018-00044
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307107262
• UDI-Public: 10841307107262
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

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?: Yes
• Device Operator: Dentist
• Device Expiration Date: 09/28/2021
• Device Model Number: 825206U
• Device Catalogue Number: 825206U
• Device Lot Number: 83674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/14/2018
• Supplement Dates Manufacturer Received: 02/16/2018
• Supplement Dates FDA Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2016
• 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: 62 YR