MAUDE Adverse Event Report: CARDIAC SURGERY MFG KERKRADE KYPHX HV-R BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Model Number C01A-J

Device Problems Break (1069); Contamination /Decontamination Problem (2895)

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

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k): this product is not approved for sale in us but a similar device with catalog# c01a, 510k # k041584 and udi (b)(4) is approved for sale in us.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 Description

Information was received from a healthcare professional via manufacturer representative regarding a patient being implanted with bo ne cement for spinal therapy.It was reported that in order to mix the cement, the powder was put in the mixer and the ampoule containing the liquid was broken off, and then suction was performed with a syringe and the cement was put in the mixer.After mixing and filling all to the bfd, the cement left in the mixer was sucked with a syringe, and then things like broken pieces of broken off ampoule were visually confirmed.There was a possibility that there were also some pieces in the bfd, so all the operations above were redone.Therefore, the kpt, mixer and the cement were replaced with another set without being used.In the sr's opinion, it may have been mixed from the top of the mixer when the cement ampoule was broken off.The product was never implanted.There were no further complications reported regarding the event.Update : it has been reported, intra-op, that the work table for preparing cement and putting it in the mixer was narrow.During the operation, when preparing cement, the ampule broke on the mixer.The cement which had been mixed by mixer was injected into bfd, and when the rest was sucked out with a syringe, something like brown glass pieces were observed.Pre-op diagnosis : compression fracture at l1 procedure involved : bkp the product did not come in contact with the patient.There were no patient complications as a result of the event.

• Brand Name: KYPHX HV-R BONE CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): CARDIAC SURGERY MFG KERKRADE; valkenhuizerlaan 16a; kerkrade 6466 ND; NL 6466 ND
• Manufacturer (Section G): CARDIAC SURGERY MFG KERKRADE; valkenhuizerlaan 16a; kerkrade 6466 ND; NL 6466 ND
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10435534
• MDR Text Key: 203829392
• Report Number: 6000033-2020-00004
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• 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: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: C01A-J
• Device Catalogue Number: C01A-J
• Device Lot Number: EL70156
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2020
• Date Device Manufactured: 01/06/2020
• 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