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

Catalog Number	904810W
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption # e2012017 report late due to asr to individual reporting transition.
Event or Problem Description
Per complaint (b)(4), during post operative check, patient experienced loss or failure of implant to integrate.

• Brand Name: SWISHPLANT 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: 8979555
• Report Number: 3001617766-2019-01432
• Device Sequence Number: 14285525
• Product Code: DZE
• UDI-Device Identifier: 10841307105992
• UDI-Public: 10841307105992
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K081396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 09/10/2019

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: 08/02/2014
• Device Catalogue Number: 904810W
• Device Lot Number: 22764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 09/10/2019
• 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: 64 YR