MAUDE Adverse Event Report: Z-SYSTEMS AG Z5; IMPLANT, ENDOSSEOUS, ROOT-FORM

Model Number Z5C-A00

Device Problem Fracture (1260)

Patient Problem Tissue Damage (2104)

Event Date 01/08/2018

Event Type  Injury  

Event Description

Patient had problem with hypersensitivity.

• Brand Name: Z5
• Type of Device: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): Z-SYSTEMS AG; werkhofstrasse 5; oensingen, solothurn 4702 ; SZ 4702
• Manufacturer (Section G): Z-SYSTEMS AG; werkhofstrasse 5; oensingen, solothurn 4702 ; SZ 4702
• Manufacturer Contact: rubino di girolamo ; werkhofstrasse 5; oensingen, solothurn 4702 ; SZ 4702
• MDR Report Key: 8183607
• MDR Text Key: 130975689
• Report Number: 3006948427-2018-02092
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132881
• 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: 10/30/2018,12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: Z5C-A00
• Device Catalogue Number: Z5C-A00
• Device Lot Number: 882005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/30/2018
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 10/30/2018
• Date Manufacturer Received: 10/30/2018
• 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: 57 YR