MAUDE Adverse Event Report: OSSDSIGN OSSDSIGN CRANIAL PSI; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Catalog Number	101010
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A rupture in the sterile barrier was noticed prior to surgery, compromising the device sterility.Device was not used, surgery was rescheduled.
Additional Manufacturer Narrative
Product and packaging investigated.Based on the information available, the exact cause of the rupture cannot be established.Corrective and/or preventative action has not been determined.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.

• Brand Name: OSSDSIGN CRANIAL PSI
• Common Device Name: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): OSSDSIGN; rapsgatan 23a; uppsala, uppsala län 75450 ; SW 75450
• Manufacturer (Section G): OSSDSIGN; rapsgatan 23a; uppsala, uppsala 75450 ; SW 75450
• Manufacturer Contact: malin kylberg ; rapsgatan 23a; uppsala, uppsala 75450 ; SW 75450
• MDR Report Key: 14192645
• Report Number: 3013282271-2022-00001
• Device Sequence Number: 20077390
• Product Code: GXN
• UDI-Device Identifier: 07350086550108
• UDI-Public: (01)07350086550108
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161090
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2023
• Device Catalogue Number: 101010
• Device Lot Number: 2150CRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male