MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH XIVE S PLUS IMPL D5.5/L11; IMPLANT, ENDOSSEOUS, ROOT-FORM

Model Number	32262415
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Osseointegrate (1863); Separation Failure (2547)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that a patient experienced a dental implant loss.
Additional Manufacturer Narrative
Fda coding being added after investigation of device.Adding component code 887.This is a follow up report to add this additional code.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.Fda coding being added after investigation of device.Adding investigation conclusions code 61.This is a follow up report to add this additional code.This is to correct and remove the codes that were initially reported - removing codes for: medical device problem code - 1863.Investigation findings code - 3221.The correct codes for this complaint are: medical device problem code - 2547.Investigation findings code - 3253 + 114.

• Brand Name: XIVE S PLUS IMPL D5.5/L11
• 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: 17265940
• Report Number: 3013111692-2023-47983
• Device Sequence Number: 12733164
• Product Code: DZE
• UDI-Device Identifier: 07392532208782
• UDI-Public: 07392532208782
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K073075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 08/31/2023

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: 32262415
• Device Catalogue Number: 26-2462
• Device Lot Number: 492185
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/30/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/31/2023
• 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: 32266040, 32266190
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown