MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH XIVE S PLUS IMPLANT D4.5/L11; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	32262452
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Reaction (2414)
Date of Event	03/25/2015
Type of Reportable Event	Serious Injury
Additional 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.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 or Problem Description
It was reported that a xive s plus implant was inserted in the jaw of a patient on (b)(6) 2013.The implant was exposed and the patient stated that they had allergic reactions and an "electric sensation" after one and a half years.The implant was removed on (b)(6) 2015.
Additional Manufacturer Narrative
Evaluation of the implant's surface properties did not show any deviations.

• Brand Name: XIVE S PLUS IMPLANT D4.5/L11
• Common Device Name: IMPLANT, ENDOSSEOUS, ROOT-FORM
• Manufacturer (Section D): DENTSPLY IMPLANTS MANUFACTURING GMBH; steinzeugstrasse 50; mannheim, baden-wurttemberg 68229 ; GM 68229
• MDR Report Key: 5826528
• Report Number: 9681851-2016-00025
• Device Sequence Number: 13538740
• Product Code: DZE
• UDI-Device Identifier: EFRI322624522
• UDI-Public: EFRI322624522
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K073075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2016

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 32262452
• Device Lot Number: B130001344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2016
• Supplement Report FDA Received Date: 09/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention