MAUDE Adverse Event Report: MIS IMPLANTS TECHNOLOGIES LTD. MGUIDE; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Model Number 128054

Device Problem Malposition of Device (2616)

Patient Problem Injury (2348)

Event Date 12/06/2018

Event Type  Injury  

Manufacturer Narrative

An investigation by the manufacturer revealed no faults in the planning or manufacturing of the surgical guide.It is therefore likely that the outcome is a result of actions made by the dentist or due to the patient's medical condition.

Event Description

A dental implant placed using a surgical guide was positioned 12 mm below its originally planned position.No severe or irreversible damage was made to the patient.

• Brand Name: MGUIDE
• Type of Device: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): MIS IMPLANTS TECHNOLOGIES LTD.; p.o. box 7; bar lev industrial park; ha zafon, 20156 00; IS 2015600
• Manufacturer (Section G): MIS IMPLANTS TECHNOLOGIES LTD.; p.o. box 7; bar lev industrial park; ha zafon, 20156 00; IS 2015600
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 8196694
• MDR Text Key: 131419537
• Report Number: 3004203816-2018-00001
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 128054
• Device Catalogue Number: MG-TMP10
• Device Lot Number: 128054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Date Manufacturer Received: 12/06/2018
• 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