MAUDE Adverse Event Report: MDT KYPHON NEUCHATEL MFG KYPHX HV-R BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Model Number C01A-J

Device Problem Leak/Splash (1354)

Patient Problem Extravasation (1842)

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

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 healthcare provider (hcp) via a manufacturer representative regarding a patient who was implanted with a spinal product type for l1 burst fracture.It was reported that incorrect product size is used for surgery.It was intended to use the end cap 4 degree, but 8 degree was placed.During the operation, the sales rep checked the size written on the end cap caddy with the physician and took out the tag.Since the product was in the place of 4 degree, it was thought that this product was 4 degree and attached it to the centerpiece.Actually, instead of 4 degree, an end cap with a size of 8 degree was placed in the place.When the event was noticed, it was immediately reported to the physician, but replacement was not performed because the implant placement had already been completed and it was judged that there was no problem even with 8 degree based on the image findings.There were no patient symptoms or complications as a result of this event.There was no delay in overall procedure time.The patient is hospitalized for continued treatment.Reoperation is scheduled for (b)(6) by screw loosening.As incorrect size of implant is used, it did not impact performance of device.On (b)(6), initial ope.Pvcr was performed for l1 vertebral body fracture was performed.(t11 / 12-l2 / 3) 2above-2below ps posterior fixation was performed.Solera 5.5 / 6.0 mas and sas were used.On (b)(6), second ope.Due to the suspect of t11 screw loosening (clear zone around the screw) and vertebral body fracture, adding fixation range and vertebroplasty were performed.The loosened screw was solera 5.5 / 6.0 mas screw.Loosening of t11 screw (clear zone around screw) was suspected and there was vertebral body fracture, so re-operation was scheduled for adding fixation range.The patient's bone quality was very fragile and it was considered that the range of fixation was short for the patient's bone quality.There is no malfunction with t2.All ps inserted in the operation on (b)(6) were replaced, and hook was used at t10, ps were inserted additionally at t10 and l4.At the cranial side and caudal side, fixation and reinforcement were performed with nesplon cable and sublaminar wiring.T9 / t10 and l4 kyphoplasty (bkp) was performed.A slight cement leak was observed from the vertebral body segmental vein of t9 (it was not be found by postoperative x-ray, but it was found by ct imaging yesterday.It was the leakage that almost be overlooked.)there was no clinical symptoms in the patient, and it was judged that there was no health damage in the patient.The report was received from the operating surgeon.The sales rep has asked the physician for a contact if there is a leakage that is noticed, so the physician provided the sales rep with the information.The operation of filling cement has been performed according to surgical technique, and the cement has been filled with a proper viscosity.Pli 20 will not be returned as it has been given to the patient by the medical institution.According to the information obtained from the doctor, the vertebral body fracture was not caused by loosening, but the patient's bone quality was extremely fragile, leading to the fracture.It was not pre-existing patient condition.

• Brand Name: KYPHX HV-R BONE CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MDT KYPHON NEUCHATEL MFG; pierre-à-bot 97; neuchâtel 2000 ; SZ 2000
• MDR Report Key: 12025143
• MDR Text Key: 281529614
• Report Number: 2953769-2021-00025
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C01A-J
• Device Catalogue Number: C01A-J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR