MAUDE Adverse Event Report: CERAROOT S.L. CERAROOT ZIRCONIUM OXIDE DENTAL IMPLANT; CERAROOT CERAMIC IMPLANT

Model Number	160.012
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Stomatitis (4489)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record (dhr) - investigation: the batch number could be verified (dentist reported wrong lot number 3870410319 instead of lot no.38701410319).Our manufacturing quality system assures that production and process controls are in place to ensure that batches confirm to the applicable specifications before they are distributed.The infection of the endosseous dental implant during the healing phase is a known inherent risk of the treatment with dental implants.The manufacturer's trend analysis confirms that the reported early failure rate associated with its dental implant is below the expected failure rate for this treatment as published in scientific literature.Antibiotic prescription is considered a useful protocol in preventing infection after dental implant surgery.The dental professional should evaluate the oral hygiene status, the amount of surgical trauma, and the overall patient health in order to determine the need or indications of such prescription.
Event or Problem Description
The clinician reported that infection was developed 7 days post surgery, the dental implant was removed, and antibiotic was prescribed.During the dental implant placement surgery the implant was placed immediately after tooth extraction in the same intervention.Antibiotic was not prescribed the day of surgery.Patient was hospitalized until infection was resolved and the patient returned home without any further problems, injuries or complications.The implant site will be let to heal until a new implant can be inserted.

• Brand Name: CERAROOT ZIRCONIUM OXIDE DENTAL IMPLANT
• Common Device Name: CERAROOT CERAMIC IMPLANT
• Manufacturer (Section D): CERAROOT S.L.; parpers,13; les franqueses del valles, barcelona 08520 ; SP 08520
• MDR Report Key: 11853819
• Report Number: 3008808095-2021-00001
• Device Sequence Number: 17254185
• Product Code: DZE
• UDI-Device Identifier: 08435453900232
• UDI-Public: 08435453900232
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K093595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Notification,Inspection,Patient Monitoring,Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2021

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: 05/17/2024
• Device Model Number: 160.012
• Device Catalogue Number: 160.012
• Device Lot Number: 38701410319
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 05/20/2021
• 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: Hospitalization
• Patient Age: 35 YR