MAUDE Adverse Event Report: INSTITUT STRAUMANN AG PALATAL IMPLANT 4.8, L 4.2MM; ENDOSSEOUS DENTAL IMPLANT

Model Number PALATAL-SYSTEM

Device Problem Failure to Osseointegrate (1863)

Patient Problems Failure of Implant (1924); Fibrosis (3167)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

The batch number could be verified.Our manufacturing q-system assures, that production and process controls are in place to ensure that batches confirm to the applicable specifications before they are distributed.  the non-integration of an endosseous dental implant during the healing phase is a known inherent risk of the treatment with dental implants.Most implant failures occur before occlusal loading (analainen et al.2009).Based on clinical studies about 1-3% of the implants fail within the first year after implantation (ganeles et al.2008).Implants may have to be removed in case one or more of the implant success criteria are not met.Implant success criteria according to buser et al.(1991) are: absence of persistent subjective complaints such as pain, foreign body sensation and /or dysesthesia.Absence of a recurrent peri-implant infection with suppuration.Absence of implant mobility.Absence of a continuous radiolucency around the implant.The manufacturer's trend analysis confirms that the reported early failure rate associated with its dental implants is below the expected failure rate for this treatment as published in the scientific literature.

Event Description

The clinician reports the implant was inserted (b)(6) 2020 in the patient's mouth.Details of surgery: implant surface not completely covered with bone.On (b)(6) 2020, non-osseointegration was verified.The device was forwarded to the manufacturer.At the event the patient experienced: mobility.No further patient complications were reported.

Manufacturer Narrative

The batch number could be verified.Our manufacturing q-system assures, that production and process controls are in place to ensure that batches confirm to the applicable specifications before they are distributed.  the non-integration of an endosseous dental implant during the healing phase is a known inherent risk of the treatment with dental implants.Most implant failures occur before occlusal loading (analainen et al.2009).Based on clinical studies about 1-3% of the implants fail within the first year after implantation (ganeles et al.2008).Implants may have to be removed in case one or more of the implant success criteria are not met.Implant success criteria according to buser et al.(1991) are: 1.Absence of persistent subjective complaints such as pain, foreign body sensation and /or dysesthesia.2.Absence of a recurrent peri-implant infection with suppuration.3.Absence of implant mobility.4.Absence of a continuous radiolucency around the implant.The manufacturer's trend analysis confirms that the reported early failure rate associated with its dental implants is below the expected failure rate for this treatment as published in the scientific literature.

Event Description

The clinician reports the implant was inserted (b)(6) 2020 in the patient's mouth.Details of surgery: implant surface not completely covered with bone.On (b)(6) 2020, non-osseointegration was verified.The device was forwarded to the manufacturer.At the event the patient experienced: mobility.No further patient complications were reported.

• Brand Name: PALATAL IMPLANT 4.8, L 4.2MM
• Type of Device: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; CH 04002
• MDR Report Key: 10614961
• MDR Text Key: 209453967
• Report Number: 0009613348-2020-54179
• Device Sequence Number: 1
• Product Code: OAT
• UDI-Device Identifier: 07630031718174
• UDI-Public: 07630031718174
• Combination Product (y/n): N
• PMA/PMN Number: K060062
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2020
• Device Model Number: PALATAL-SYSTEM
• Device Catalogue Number: 042.336S
• Device Lot Number: KJ694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/12/2021
• Event Location: Other
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR