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

Catalog Number	104713P
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint (b)(4), a patient with a dental implant experienced an allergic reaction and infection.Osseointegration failure was also reported.The implant was explanted five months after initial placement.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated for report submission date and to report device evaluation results.Updated for device return date, for follow-up report submitter, for awareness date and for report type and follow-up number.Updated for follow-up type, for device evaluation status and event problem and evaluation codes.Correction: additional information requested regarding report of patient allergic reaction.Physicians who applied implants were interviewed and it was determined that allergic reaction was accidently selected on the complaint form.The patient did not experience an allergic reaction.Based on additional information received, this complaint does not meet reportability requirements as an mdr.However, this complaint does meet reportability requirements for submission on the alternative summary report and will be reclassified.

• Brand Name: SCREWPLANT 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: 8488511
• Report Number: 3001617766-2019-00148
• Device Sequence Number: 1883956
• Product Code: DZE
• UDI-Device Identifier: 10841307105138
• UDI-Public: 10841307105138
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K061319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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 Expiration Date: 09/27/2014
• Device Catalogue Number: 104713P
• Device Lot Number: 23587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/10/2019
• 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: 52 YR