MAUDE Adverse Event Report: INTEGRUM AB OPRA IMPANT SYSTEM

Model Number	1820
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2021
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: OPRA IMPANT SYSTEM
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 12154105
• Report Number: 3011386779-2021-00052
• Device Sequence Number: 11800946
• Product Code: PJY
• UDI-Device Identifier: 07340152100726
• UDI-Public: 07340152100726
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/12/2021
• 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: Required Intervention