SURGIGUIDE 37504

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-02 for SURGIGUIDE 37504 manufactured by Dentsply Implants (a Division Of Dentsply Ih Ab).

MAUDE Entry Details

• Report Number: 9612468-2020-00040
• MDR Report Key: 9776042
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2020-03-02
• Date of Report: 2020-02-29
• Date of Event: 2020-01-31
• Date Mfgr Received: 2020-01-31
• Date Added to Maude: 2020-03-02
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. KARL NITTINGER
• Manufacturer Street: 221 W. PHILADELPHIA ST. SUITE 60W
• Manufacturer City: YORK, PA
• Manufacturer Country: US
• Manufacturer Phone: 8494424
• Manufacturer G1: DENTSPLY IMPLANTS N.V.
• Manufacturer Street: RESEARCH CAMPUS 10
• Manufacturer City: HASSELT LIMBURG, B-3500
• Manufacturer Country: BE
• Manufacturer Postal Code: B-3500
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SURGIGUIDE
• Generic Name: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• Product Code: NDP
• Date Received: 2020-03-02
• Returned To Mfg: 2020-02-10
• Model Number: NA
• Catalog Number: 37504
• Lot Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)
• Manufacturer Address: AMINOGATAN 1 MOLNDAL, VASTRA GOTALANDS LAN [SE-14] S-43121 SW S-431 21

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-02