MAUDE Adverse Event Report: DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) ANKYLOS C/X IMPLANT; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number 31010408

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

This event is reportable per 21 cfr part 803.The device was evaluated and found to be within specification.

Event Description

According to the available information a male patient received an ankylos a9.5 dental implant on (b)(4) 2013 in region 31 (fdi 47).On (b)(6) 2013 the implant was restored with an implant-tooth supported fixed bridge.The implant and the tooth #29 (fdi 45) broke on (b)(4) 2020 and were removed.The x-ray shows the implant 47 with a slight vertical bone loss.The prosthetic cantilever is appr.11.5 mm.The implant was inserted after some horizontal bone loss.The bridge on the implant and the natural tooth contained and restored the teeth 45, 46, and 47.That means, this bridge was in the masticatory center where the chewing forces are the highest.The patient is a bruxist, that means even higher forces.The restoration has a long cantilever.A natural tooth has always a resilience, an implant does not.Therefore, the implant had to take the whole load.Vertical bone loss takes the support from the implant, which is needed, especially by smaller diameters like 3.5 mm.The implant alone without the support by the bone cannot withstand the high chewing load.All these factors led to overload of the implant that broke and in consequence the tooth broke as well.

• Brand Name: ANKYLOS C/X IMPLANT
• Type of Device: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB); aminogatan 1; molndal, vastra gotalands lan [se-14] S-431 21; SW S-431 21
• Manufacturer (Section G): DENTSPLY IMPLANTS MANUFACTURING GMBH; steinzeugstrasse 50; mannheim, 68229 ; GM 68229
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 11283497
• MDR Text Key: 233461338
• Report Number: 9612468-2021-00001
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K140347
• 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: 02/04/2021

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 Operator: Health Professional
• Device Catalogue Number: 31010408
• Device Lot Number: 0020054445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 02/04/2021
• 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
• Patient Age: 75 YR