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

Catalog Number 101010

Device Problems Tear, Rip or Hole in Device Packaging (2385); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 03/25/2022

Event Type  malfunction  

Event Description

A rupture in the sterile barrier was noticed prior to surgery, compromising the device sterility.Device was not used, surgery was rescheduled.

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
• Type of Device: 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
• MDR Text Key: 299153918
• Report Number: 3013282271-2022-00001
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 07350086550108
• UDI-Public: (01)07350086550108
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161090
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2022
• 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 Age: 57 YR
• Patient Sex: Male