MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH DIRECT ABUTM. 4.5/5.0-Ø5, 4MM; IMPLANT, ENDOSSEOUS, ROOT-FORM

Model Number	24530
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	02/06/2023
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.This mdr submission is a late submission.A capa has been issued.
Additional Manufacturer Narrative
Additional fda coding being added after investigation of device.Adding type of investigation code 10.This is a follow up report to add this additional code.Additional fda coding being added after investigation of device.Adding component code 887.This is a follow up report to add this additional code.Device received for this event is being corrected from osseospeed tx 4.5 - 9 mm catalog # 24951 to direct abutm.4.5/5.0-ø5, 4mm catalog # 24530.This is to correct and remove the codes that were initially reported - removing codes for: health effect - clinical code - 1924.The correct codes for this complaint are: health effect - clinical code - 4580.

• Brand Name: DIRECT ABUTM. 4.5/5.0-Ø5, 4MM
• 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: 16775138
• Report Number: 3013111692-2023-40245
• Device Sequence Number: 17896166
• Product Code: DZE
• UDI-Device Identifier: 07392532067358
• UDI-Public: 07392532067358
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K053384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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 Model Number: 24530
• Device Catalogue Number: 24530
• Device Lot Number: 91925
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/13/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 06/21/2023
• 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: 2 CROWNS, 2 ABUTMENTS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown