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

Model Number Palatal-System

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2021

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 removal of a dental implant during surgery without the replacement of another dental implant is a known inherent risk of the procedure due to either lack of primary stability of the implant (patienor procedure related).It may also include the removal of an implant after osseointegration due to either the clinician's or patient¿s decision.The manufacturer¿s trend analysis confirms that usually procedural errors and/or patient's condition contribute to the event.

Event Description

The clinician reports that the day the implant was placed in the patient's mouth, failure occurred upon insertion.Details of surgery: primary stability not achieved.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.

• 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 ; SZ 04002
• Manufacturer (Section G): INSTITUT STRAUMANN AG; peter merian-weg 12; basel 04002 ; SZ 04002
• Manufacturer Contact: jennifer jackson ; 60 minuteman road; andover, MA 01810 ; 9787472509
• MDR Report Key: 11887984
• MDR Text Key: 256314580
• Report Number: 0009613348-2021-36625
• Device Sequence Number: 1
• Product Code: OAT
• UDI-Device Identifier: 07630031718174
• UDI-Public: 07630031718174
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K060062
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/26/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2021
• Device Model Number: Palatal-System
• Device Catalogue Number: 042.336S
• Device Lot Number: MK749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/26/2021
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR