MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON EXPRESS; DISPENSER, CEMENT

Model Number F06B

Device Problem Expiration Date Error (2528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a field representative regarding a bone filler device used for spinal therapy.It was reported that intra-op, the bone filler used was expired.There is no kyphon consigned at the hospital, so all the products were sent by medtronic to the hospital one day before this surgery.Nurse took the material to the operating room.The sticker was glued in the expense sheet.After surgery the purchase department noticed that the product used was expired.There were no patient complications as a result of this event.The procedure was successfully completed using the original product and two levels were implanted.There were no further complications reported regarding the event.

• Brand Name: KYPHON EXPRESS
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10228804
• MDR Text Key: 197594573
• Report Number: 1030489-2020-00781
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 00643169097254
• UDI-Public: 00643169097254
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2020
• Device Model Number: F06B
• Device Catalogue Number: F06B
• Device Lot Number: WI530082
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2020
• Date Device Manufactured: 05/09/2018
• 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: 75 YR