MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPANT SYSTEM

Model Number 1820

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 06/02/2021

Event Type  Injury  

Event Description

On 2021-07-05: qa at integrum was notified about a patient having problems with his axor falling off.No report form have been provided.Manufacturing batch has been reviewed and no deviation related to the product was found.No complication on the abutment itself could be detected, the abutment was stable, no black secretion has been reported.The axor was serviced yet it didn't solve the issue.The final attempt was to replace the abutment.The replacement surgery was performed on (b)(6) 2021.It went according to plan and the patient was fitted with bigger size abutment to secure the press-fit.The replaced abutment was sent back to integrum for technical inspection.No report form was provided though.On 2021-07-07: visual inspection confirms wear on the abutment head.The product was implanted more than 3 years ago (s2 surgery on (b)(6) 2018).

• Brand Name: OPRA IMPANT SYSTEM
• Type of Device: OPRA IMPANT SYSTEM
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• Manufacturer (Section G): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• Manufacturer Contact: sally skog ; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 12154105
• MDR Text Key: 261245091
• Report Number: 3011386779-2021-00052
• Device Sequence Number: 1
• Product Code: PJY
• UDI-Device Identifier: 07340152100726
• UDI-Public: 07340152100726
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 07/12/2021

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: No Information
• Device Expiration Date: 07/01/2022
• Device Model Number: 1820
• Device Catalogue Number: 1220
• Device Lot Number: 6372/P275518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention