MAUDE Adverse Event Report: IMPLANT DIRECT LLC REPLUS IMPANT; DENTAL IMPLANT

Catalog Number	704710
Medical Device Problem Codes	Failure to Osseointegrate (1863); Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Abscess (1690); Asthma (1726); Autoimmune Disorder (1732); Edema (1820); Fistula (1862); Granuloma (1876); Hemorrhage/Blood Loss/Bleeding (1888); Hyperplasia (1906); High Blood Pressure/ Hypertension (1908); Failure of Implant (1924); Unspecified Infection (1930); Infiltration into Tissue (1931); Inflammation (1932); Nerve Damage (1979); Pain (1994); Swelling (2091); Thyroid Problems (2102); No Consequences Or Impact To Patient (2199); Discharge (2225); Anxiety (2328); Discomfort (2330); Osteolysis (2377); Impaired Healing (2378); Osteopenia/ Osteoporosis (2651); No Information (3190); No Code Available (3191); Cancer (3262)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number: 2012017 conclusion codes reported: cause traced to user, adverse event related to patient condition, unintended use error caused or contributed to event, no problem detected, cause cannot be traced to device, cause not established, appropriate term/code not available.All devices received were evaluated by manufacturer.The exception for non-evaluated devices can be found on attached line list, code 3221, which designates no findings available, as devices were not returned for investigation.For q2, no complaints have necessitated remedial action as complaints are monitored to ensure market performance, consistent with historical and expected performance.Additionally, of complaints evaluated, no product issues have been identified.Update to eligible q1 asr report evaluation result and conclusion codes can be found on attached line list.Additionally, the following complaints were reported on q1 asr and are ineligible, therefore no updates will be provided.Voided complaints: (b)(4)-duplicate, (b)(4)-duplicate, (b)(4)-duplicate, (b)(4)-duplicate.3500a: (b)(4) - reported on 3500a 3001617766-2018-00067, (b)(4) - reported on 3500a 3001617766-2018-00153.Not reportable: (b)(4).
Event or Problem Description
This report summarizes 2403 injury complaints associated with class ii, endosseous dental implants (dze) for reporting quarter 2; april 1, 2018 through june 30, 2018.It contains information on early implant failures and late or long-term implant failures.Early failures include cases of failure to osseointegrate or positioning problems, i.E.Lack of primary stability.Osseointegration occurs when bone cells attach themselves directly to the titanium surface, essentially locking the implant into the bone.In cases of lack of osseointegration, this has not been achieved.Positioning is considered the key factor in clinical success of an implant in the short term.With positioning failure, primary mechanical stability cannot be achieved.Late or long-term failure include cases of loss of integration.In loss of integration, an implant has initially osseointegrated into the bone, however, over time bone loss may have occurred around the implant site, requiring the removal of the implant.This asr report will provide a summary of complaints deemed as serious injuries due to necessitating medical or surgical intervention.Device problem codes reported: failure to osseointegrate, positioning problem, loss of osseointegration, adverse event without identified device or use problem.Patient problem codes reported: implant, failure of, osteopenia, healing, impaired, osteolysis, discomfort, discharge, no consequences or impact to patient, wound dehiscence, autoimmune disease, edema, granuloma, hemorrhage, hypertension, infection, inflammation, infiltration of tissue, nerve damage, pain, hyperplasia, fistula, asthma, abcess, thyroid problems, anxiety, cancer, no code available, no information, swelling.

• Brand Name: REPLUS IMPANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT LLC; 3050 east hillcrest road; thousand oaks CA 91362
• MDR Report Key: 7732860
• Report Number: 3001617766-2018-00177
• Device Sequence Number: 1365677
• Product Code: DZE
• UDI-Device Identifier: 10841307104292
• UDI-Public: 10841307104292
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 2403
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 06/20/2018
• Device Catalogue Number: 704710
• Device Lot Number: 42587
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention