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

Model Number	F06B
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: DISPENSER, CEMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10228804
• Report Number: 1030489-2020-00781
• Device Sequence Number: 594713
• Product Code: KIH
• UDI-Device Identifier: 00643169097254
• UDI-Public: 00643169097254
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2020

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: 05/03/2020
• Device Model Number: F06B
• Device Catalogue Number: F06B
• Device Lot Number: WI530082
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 07/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR