MAUDE Adverse Event Report: HAGER & MEISINGER GMBH INFINITY OCTAGON BONE LEVEL; DENTAL IMPLANT

Model Number	504810BL
Medical Device Problem Codes	Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Swelling (2091)
Date of Event	02/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This implant loss suggests that the source of the problem was likely to stem from procedural errors.Correct use and procedural instructions are described in this product's instructions for use.
Event or Problem Description
Swelling, fistula, infection and inadequate bone quality/bone quantity were reported.Bone quality at the time of implant failure type iv.Time of loss in relation to the implantation was before prosthetic restoration.Primary stability and osseointegration was not achieved.Augmentation procedure was not performed at the time of surgery.

• Brand Name: INFINITY OCTAGON BONE LEVEL
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HAGER & MEISINGER GMBH; hansemannstrasse 10; neuss nordrhein-westfalen, germany D-414 68; GM D-41468
• MDR Report Key: 8634042
• Report Number: 1287163-2019-00613
• Device Sequence Number: 13954419
• Product Code: DZE
• UDI-Device Identifier: E0HM504810BL1
• UDI-Public: E0HM504810BL1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/29/2019

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
• Operator of Device: Health Professional
• Device Model Number: 504810BL
• Device Catalogue Number: 504810BL
• Device Lot Number: B40705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/22/2019
• 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: 49 YR