MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH IMPL. PICK-UP DESIGN EV 4.2; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number 26241

Device Problems Failure to Osseointegrate (1863); Separation Failure (2547)

Patient Problem Failure of Implant (1924)

Event Date 11/14/2023

Event Type  Injury  

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 Description

It was reported that a patient experienced a dental implant loss.

• Brand Name: IMPL. PICK-UP DESIGN EV 4.2
• Type of Device: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• 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: 18317029
• MDR Text Key: 330330819
• Report Number: 3013111692-2023-63891
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 07392532192388
• UDI-Public: 07392532192388
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 12/13/2023

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: 26241
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/07/2023
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: IMPLANT
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male