MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH ANKYLOS C/X IMPLANT A 9.5 Ø 3.5 /L 9.5; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number 31010408

Device Problems Failure to Osseointegrate (1863); Patient-Device Incompatibility (2682); Extrusion (2934)

Patient Problems Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Inflammation (1932); Ambulation Difficulties (2544)

Event Date 02/05/2015

Event Type  Injury  

Manufacturer Narrative

While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.This report is for the fifth device.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

It was reported that a patient who was implanted with seven ankylos c/x implants, had to have all of the implants removed due to mobility, periimplantitis and "extrusion from bone".The clinician expressed the suspicion that there may be an allergy to titanium.According to the available information three ankylos c/x implants were inserted in the maxilla of a (b)(6) patient.Simultaneous augmentation with "allograft particulate" and "dbm putty" was done.The implants were removed five months later.The same patient also had four implants that were inserted in the mandible and were removed four months later.

Manufacturer Narrative

Evaluation of the implant's surface properties did not show any deviations.

• Brand Name: ANKYLOS C/X IMPLANT A 9.5 Ø 3.5 /L 9.5
• Type of Device: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): DENTSPLY IMPLANTS MANUFACTURING GMBH; steinzeugstrasse 50; mannheim, baden-wurttemberg 68229 ; GM 68229
• Manufacturer (Section G): DENTSPLY IMPLANTS MANUFACTURING GMBH; steinzeugstrasse 50; mannheim, baden-wurttemberg 68229 ; GM 68229
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5204564
• MDR Text Key: 30514064
• Report Number: 9681851-2015-00018
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 31010408
• Device Lot Number: B120008425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2015
• 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
• Patient Age: 38 YR