MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISSPLANT STRAIGHT DRILL 4.2MMD SHORT PRODUCT CODE SPD4.2S; POWERED BONE DRILL

Model Number SPD4.2S

Device Problems Device Markings/Labelling Problem (2911); Missing Information (4053)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Lack of grooving and laser markings.Distributor received the correct part, however they received the previous revision of this drill which is now marketed with the new grooving's and laser markings.Distributor requested replacements with the newest revisions.

• Brand Name: SWISSPLANT STRAIGHT DRILL 4.2MMD SHORT PRODUCT CODE SPD4.2S
• Type of Device: POWERED BONE DRILL
• 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 e hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: adrienne stott ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 7475360
• MDR Text Key: 107324063
• Report Number: 3001617766-2018-00066
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10841307117476
• UDI-Public: 10841307117476
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: SPD4.2S
• Device Catalogue Number: SPD4.2S
• Device Lot Number: 72432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2015
• 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