MAUDE Adverse Event Report: DENTSPLY SIRONA K.K. DDSC FACTORY SURGIGUIDE - 2 IMPLANTS; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number UNIQUE REFERENCE PER ORDER (CU

Device Problem Positioning Failure (1158)

Patient Problem Failure of Implant (1924)

Event Date 03/01/2023

Event Type  Injury  

Event Description

In this event it is reported that surgiguide broke during use.Clinician postponed surgery for a later date.

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Product return is requested and product will be evaluated after receipt.In case any new or additional information will be gained from this investigation a follow-up report will be sent.Trend is tracked and monitored.

Manufacturer Narrative

Fda coding was missed in the initial report.Adding additional investigation findings codes 170 + 114.This is a follow up report to add this additional code.Fda coding was missed in the initial report.Adding additional type of investigation codes 3331 + 4114.This is a follow up report to add this additional code.Fda coding was missed in the initial report.Adding additional investigation conclusions code 12.This is a follow up report to add this additional code.

• Brand Name: SURGIGUIDE - 2 IMPLANTS
• Type of Device: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): DENTSPLY SIRONA K.K. DDSC FACTORY; 1-5-21 katsushima shinagawa-ku; tokyo 140-0 012; JA 140-0012
• Manufacturer (Section G): DENTSPLY SIRONA K.K. DDSC FACTORY; 1-5-21 katsushima shinagawa-ku; tokyo 140-0 012; JA 140-0012
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 16581833
• MDR Text Key: 311659939
• Report Number: 3007362683-2023-00029
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNIQUE REFERENCE PER ORDER (CU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/01/2023
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 03/01/2023
• Supplement Dates FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: #23: 26312:ASTRA TECH IMPLANT EV 3.6 S ¿ 9 MM.
• Patient Outcome(s): Required Intervention