MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH ANK STAND C/ ABUT B/3/6STRAI; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	31021120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a dental implant loss.
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Section h6 was done based on the information provided by the initial reporter and our long-time experience in the investigation of similar complaints.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.
Additional Manufacturer Narrative
Additional fda coding being added after investigation of device.Adding additional type of investigation code 10.This is a follow up report to add this additional code.Correcting udi # from (b)(4) to (b)(4).This is a follow up report to correct the udi #.Device received for this event is being corrected from ank bal postc/4,5strai catalog # 17-3154 to ank stand c/ abut b/3/6strai catalog # 31021120.This is a follow up report to correct this information.This is to correct and remove the code that were initially reported - removing code for: investigation conclusions code - 50.

• Brand Name: ANK STAND C/ ABUT B/3/6STRAI
• Common Device Name: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer (Section G): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 17450151
• Report Number: 3013111692-2023-51228
• Device Sequence Number: 15271418
• Product Code: DZE
• UDI-Device Identifier: 07392532215292
• UDI-Public: 07392532215292
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K041509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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: 31021120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/12/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IMPLANT 31010430
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown