MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH XIVE S PLUS IMPLANT D4.5/L13; IMPLANT, ENDOSSEOUS, ROOT-FORM

Catalog Number	32262453
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Pain (1994)
Date of Event	11/25/2015
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.Evaluation of the implant's surface properties did not show any deviations.
Event or Problem Description
It was reported that a xive s plus implant was inserted in the jaw of a patient.The patient had postoperative pain for several days, even though antibiotics and painkillers were being taken.A dvt was made after implantation and there was no contact of the implant to surrounding nerve structures.The implant was placed completely intraosseous.The diagnostic findings before explantation are described as "infection" and "periimplantitis".The clinician expressed the suspicion that there may be an allergy to titanium because the patient had no more pain after removal of the implant approximately two weeks later.

• Brand Name: XIVE S PLUS IMPLANT D4.5/L13
• 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: 5486303
• Report Number: 9681851-2016-00006
• Device Sequence Number: 247209
• Product Code: DZE
• UDI-Device Identifier: EFRI322624532
• UDI-Public: EFRI322624532
• 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: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/15/2016

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: 32262453
• Device Lot Number: B120007731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2016
• Initial Report FDA Received Date: 03/08/2016
• 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
• Patient Age: 57 YR