MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC HEX DRILL

Model Number HD2.5

Device Problems Material Deformation (2976); Positioning Problem (3009); Device Handling Problem (3265)

Patient Problems Edema (1820); Pain (1994); Sinus Perforation (2277); Impaired Healing (2378)

Event Date 06/05/2017

Event Type  Injury  

Manufacturer Narrative

Both the hex drill and implant were received for inspection.Both products are within specification.The implant was placed on the drill in order to evaluate the fit.There was full engagement and retention.This is an unforeseen event that does not necessitate remedial action.Evaluation summary: appearance: hex drill shows some damage.Specification should be: length: 0.89 ± 0.01 specification as found: 0.8920, diameter: 0.0919/0.0925 specification as found: 0.0921.Comments: hex drill is damaged around the latch area where the corners are rounded, this is not a manufacturing error but caused by excessive torque force by the customer.All other features meet specifications.Also placed the hex drill into the implant that was also returned by the customer and we got full engagement and retention.Date of inspection: 07/31/2017.

Event Description

From clinician: hd2.5 defect.Dr claims that "the implant just fell out and didn't stay".An immediate implant was placed following the extraction tooth #15.An hd2.5 engine driver was used to place implant (size 4.2 x 10mm).During the placement, the implant fell off the hd2.5 driver and into the sinus.This was caused by a faulty driver tip.The implant was retrieved by an oral surgeon the next day.The patient received and invasive lateral window sinus opening surgery causing large psychological impact.In addition, the patient suffered pain and swelling as a result of this procedure.

• Brand Name: HEX DRILL
• Type of Device: HEX DRILL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest dr.; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest dr.; thousand oaks CA 91362
• Manufacturer Contact: evan garner ; 3050 e hillcrest dr.; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 6760529
• MDR Text Key: 81637036
• Report Number: 3001617766-2017-00004
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: HD2.5
• Device Catalogue Number: HD2.5
• Device Lot Number: 70102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR