MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON CEMENT DELIVERY SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	VPK013B
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a health care provider via a manufacturer representative regarding a patient with unknown indication for kyphoplasty.It was reported that intra-operatively, cement canister disengaged 3 times during cement delivery connected to 13guage trochar which was inserted into patient.Procedure continued with great difficulty to insert cement into vertebrae with 13guage trochar connected to cement delivery system.Patient symptoms or complications associated with this event were unknown.The canister came in contact with patient and was in use injecting cement into vertebrae when popped off.

• Brand Name: KYPHON CEMENT DELIVERY SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11312447
• Report Number: 1030489-2021-00178
• Device Sequence Number: 11690411
• Product Code: LXH
• UDI-Device Identifier: 00643169637467
• UDI-Public: 00643169637467
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2021

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: 05/29/2021
• Device Model Number: VPK013B
• Device Catalogue Number: VPK013B
• Device Lot Number: 0220442399
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1