MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON® CEMENT DELIVERY SYSTEM; ARTHROSCOPE

Model Number	CDS3A
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
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 provider (hcp) via a manufacturer representative regarding a patient having spinal therapy.Pre-operative diagnosis for this procedure was l1 fx.It was reported that t15s was used to access the l1 vertebral body on right pedicle until shy anterior wall per labeling.The trocar was removed and balloon was inserted.Balloon inflated only slightly despite being very high pressure (>400 psi).First pack of xpede cement was mixed for 20 seconds until slightly under doughy and cds cartridges were filled.The bone filled was primed with the cds gun and cement was just under doughy and inserted into cannula to the anterior portion of l1.Immediately noted there was high pressure as bone filler kept popping out of the locking mechanism on cannula and fill was only at the lateral and posterior wall despite physician holding the bone filler in place.The cds gun starts leaking right away.He rethreads the cds gun but still has trouble with leaking.Eventually stops working so we use a fresh bone filler and fresh cds cartridge.Still having the same issue with leaking and cds gun not pushing the cement into body.He remixes the another back of xpede cement this time to 15 seconds.Very loose cement.Plunged it into new cds cartridges places it on a bone filler that is fully expunged of cement.Continued to try injecting.Again bone filler kept popping out, cementgun is leaking and not pushing any cement despite the cement being much looser this time.Finally, physician requests the drill (from ocn003) and the curved needle (vpt02a) where he was able to get the needle to the contra lateral side.He mixes hvr for 30 seconds (very loose) because his experience is when the cement is doughy, the cds gun is inadequate at pushing it through the curved tip.He proceeds slowly to inject the hvr using the curved needle and a fresh cds gun and cartridge.Cds fails to push cement and starts leaking.He then pulls the curved needle back slightly and it suddenly depressurizes (because the curve top straightens when pulled into cannula) and lots of cement comes out suddenly.Luckily it was in contra lateral and inferior side of vertebral body.Our cds system is inadequate at getting the cement past the bend of the curved needle despite cement being very loose and difficult to work with.There were no patient symptoms reported.

• Brand Name: KYPHON® CEMENT DELIVERY SYSTEM
• Common Device Name: ARTHROSCOPE
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13950130
• Report Number: 1030489-2022-00299
• Device Sequence Number: 17341534
• Product Code: HRX
• UDI-Device Identifier: 00643169463455
• UDI-Public: 00643169463455
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2022

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: 09/24/2022
• Device Model Number: CDS3A
• Device Catalogue Number: CDS3A
• Device Lot Number: 0223128392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 03/30/2022
• Date Device Manufactured: 10/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female