MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON HV-R BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Model Number	C01B
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
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 healthcare professional via field representative regarding patient with symptoms of osteoporotic vertebral compression fracture (vcf) l5 involved in the reported event.It was reported that during procedure, cement was mixed for 60 seconds and bone fillers were loaded.Cement was used at 12 minutes post mix and two out of 6 bone fillers were thick but usable, however the other 4 had hardened in the bone fillers.Room was in normal temperature range and bone fillers were not handled after filling.Labeling was followed throughout the procedure.No patient adverse events associated with the cement.Cement mixed for 60 seconds.No malfunction of the cds system during use.Cement was doughy and homogenous prior to delivery into the patient.There were no patient symptoms or complications reported as a result of this event.Procedure was completed successfully with new product.Patient is alive and no injury.On 2021-jul-01, received additional information that procedure was kyphoplasty.There was delay in overall procedure time for 15 minutes.This event occurred on the back table.2-bone filler used in the patient.Remaining 4 bone fillers were cement hardened was not used in the patient, and it was discarded.2 fillers worth of cement (approx.3cc) remains in patient.

• Brand Name: KYPHON HV-R BONE CEMENT
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 12225547
• Report Number: 1030489-2021-00971
• Device Sequence Number: 11872378
• Product Code: NDN
• UDI-Device Identifier: 00643169097834
• UDI-Public: 00643169097834
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K041584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2021

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: 02/29/2024
• Device Model Number: C01B
• Device Catalogue Number: C01B
• Device Lot Number: 0010711229
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 54