MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH OSSEOSPEED TX 5.0S - 15 MM; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	24974
Medical Device Problem Codes	Loss of Osseointegration (2408); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pocket Erosion (2013); Insufficient Information (4580)
Date of Event	12/01/2023
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.No information besides implant failure and implant system was received so far.Additional information and product return is requested.Follow-up report will be sent in case additional information will be received.Trend is tracked and monitored.This mdr submission is a late submission.A capa has been issued.
Additional Manufacturer Narrative
Additional information received: adding udi # (b)(4).Adding implanted date (b)(6) 2011.Adding explanted date (b)(6) 2023.This is a follow up report for this additional information.Device received for this event is being corrected from unknown atis implant catalog # unknown atis implant to osseospeed tx 5.0s - 15 mm catalog # 24974.Correcting lot# from unk to 82766.This is a follow up report for this corrected information.This is to correct and remove the codes that were initially reported - removing codes for: health effect - clinical code: remove 4580; medical device problem code remove 3190.The correct codes for this complaint are: health effect - clinical code: add 2013; medical device problem code add 2408.This is a follow up report to correct this code.

• Brand Name: OSSEOSPEED TX 5.0S - 15 MM
• 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: 18443059
• Report Number: 3013111692-2024-65692
• Device Sequence Number: 12495043
• Product Code: DZE
• UDI-Device Identifier: 07392532108167
• UDI-Public: 07392532108167
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 02/29/2024

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: 24974
• Device Lot Number: 82766
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/01/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown