MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC REACTIVE IMPLANT; DENTAL IMPLANT

Model Number	753713
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Failure of Implant (1924); Inflammation (1932); Osteopenia/ Osteoporosis (2651)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot information unknown and if it becomes available a follow-up report will be submitted.
Event or Problem Description
Per complaint (b)(4), during clinical procedure, patient experienced loss or failure of implant to integrate.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated b6 to report device evaluation results.Updated d 4 for the lot number and the expiration date.D10 for the evaluation date.Updated g1-g2 for follow-up report submitter, g5 for the pmk510 number and g7 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status, h4 for manufacture date and h6 method, result and conclusion codes.

• Brand Name: REACTIVE IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 9621130
• Report Number: 3001617766-2020-00733
• Device Sequence Number: 2513315
• Product Code: DZE
• UDI-Device Identifier: 10841307103615
• UDI-Public: 10841307103615
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K080633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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 Expiration Date: 06/28/2015
• Device Model Number: 753713
• Device Catalogue Number: 753713
• Device Lot Number: 27478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 04/16/2020
• 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: 41 YR