MAUDE Adverse Event Report: ST PAUL PORTEX; DELTEC GRIPPERS

Device Problems Peeled/Delaminated (1454); Separation Problem (4043)

Patient Problems Foreign Body Reaction (1868); Failure of Implant (1924)

Event Date 09/12/2020

Event Type  Injury  

Event Description

After a spinal procedure was completed, one of the spinal needles noticed to be shorter.The event described approximately 50mm shorter from hub.Then realized remaining portion was in the patients back.Patient was referred to spinal surgeons at another hospital to have removal.On december 11th the needle was successfully removed and patient was discharged.

• Brand Name: PORTEX
• Type of Device: DELTEC GRIPPERS
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11211225
• MDR Text Key: 228154519
• Report Number: 3012307300-2021-00623
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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