MAUDE Adverse Event Report: Z-SYSTEMS AG Z-LOOK3; ENDOSSEOUS DENTAL IMPLANT ROOT FORM

Model Number Z3-EVO-36-10

Device Problems Mechanical Problem (1384); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 09/22/2014

Event Type  Injury  

Event Description

Biomechanical overload: confusion on implant type by implantologist, an implant to small in diameter was inserted, out of indication.

• Brand Name: Z-LOOK3
• Type of Device: ENDOSSEOUS DENTAL IMPLANT ROOT FORM
• Manufacturer (Section D): Z-SYSTEMS AG; bittertenstrasse 15; oensingen, solothurn 4702 ; SZ 4702
• Manufacturer (Section G): Z-SYSTEMS AG; bittertenstrasse 15; oensingen, solothurn 4702 ; SZ 4702
• Manufacturer Contact: ralf lüttmann ; bittertenstrasse 15; oensingen, solothurn 4702 ; SZ 4702 ; 1623886969
• MDR Report Key: 5203405
• MDR Text Key: 30455457
• Report Number: 3006948427-2014-00704
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/27/2014,11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 05/30/2015
• Device Model Number: Z3-EVO-36-10
• Device Catalogue Number: Z3 EVO-36-10
• Device Lot Number: 14465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/27/2014
• Device Age: 1 YR
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 10/27/2014
• Date Manufacturer Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other
• Patient Age: 61 YR