MAUDE Adverse Event Report: DENTSPLY IMPLANTS N.V. ISUS IMPLANT SUPERASTRUCTURES; ENDOSSEOUS DENTAL IMPLANT ABUTMENT

Catalog Number 36302-3

Device Problems Break (1069); Positioning Failure (1158)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Type  Injury  

Event Description

According to the available information an isus bar structure was manufactured for a prosthetic restoration in the maxilla, stabilized by three competitor implants (nobel biocare, unknown type).It was reported that the structure no longer fit and one of the implants broke under function.The broken implant was removed.

Manufacturer Narrative

No further information about the clinical situation, the superstructure or the time elapsed between insertion and fracture is available.Because intervention was required, this event is reportable per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Manufacturer Narrative

The device was evaluated and found to be within spec.

• Brand Name: ISUS IMPLANT SUPERASTRUCTURES
• Type of Device: ENDOSSEOUS DENTAL IMPLANT ABUTMENT
• Manufacturer (Section D): DENTSPLY IMPLANTS N.V.; hasselt ; BE
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; ste. 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4860118
• MDR Text Key: 5851528
• Report Number: 3007362683-2015-00007
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K122424
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 36302-3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention