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

Catalog Number C01A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Weakness (1967); Pain (1994); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the patient underwent bkp at th12 without any intraoperative adverse events.The rationale for longer period of hospitalization prior to the surgery was reported to be stabilization of the fractured segment with a body cast.During postoperative hospitalization slight decreased physical strength and muscle weakness were noted, for which long-term rehabilitation treatment was required.

Manufacturer Narrative

(b)(4): 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.

Manufacturer Narrative

Additional info.

Event Description

It was reported that the physician provided the rationale for his causality assessment for the events decreased physical strength and muscle weakness as both events were attributed to preoperative prolonged bed rest.Decreased physical strength and muscle weakness were not related to product.

Event Description

An additional adverse event was reported from the patient's 4-year postoperative crf.On (b)(6) 2015, the pain recurred.On the same date (i.E., at the patient's follow-up visit), the patient complained of pain rated as approximately 3 on nrs.At the time of previous follow-up visit on (b)(6) 2014 during 3-year follow up period, no back pain was observed.The soft corset was instructed because the x-ray showed incomplete bone fusion at the bkp-treated level.The event severity was mild and the outcome was reported to be unknown with an unknown outcome date because the observation was being continued.The physician considered that the event recurrence of pain was due to the patient-specific factor and was not causally related to the bkp product.He also commented that the pain was just induced by activities of the patient's daily living and therefore it could not be determined that the worsening of the nrs score observed in this patient exactly suggested worsening of the back pain.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was reported from the patient¿s 5 years postoperative "crf" on (b)(6) 2017.As of (b)(6) 2016, the patient had back pain which is considered to be attributable to spinal treatment.The back pain developed in 2015.The other findings included non-union.Bisphosphonate and active-form vitamin d3 preparation were administered as osteoporosis drug.The doctor commented that the treatment was effective for the patient.With the completion of the 5-year observation, whole studies were closed.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was reported from the patient¿s 5 years postoperative "crf" on (b)(6) 2017.As to the drug use situation, bisphosphonate and active vitamin d3 formulation are still continuing administration even at the time of judgment date after the investigation, which were noted.The doctor commented that the recurrence of the previous pain is due to the change in pain during daily life.Since it was nrs 2 at the time of observation, it was scheduled to be recovered on (b)(6) 2016.There is no other adverse event.

• Brand Name: KYPHX® HV-R¿ BONE CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MDT KYPHON SUNNYVALE MFG; 1221 crossman ave.; sunnyvale CA 94089
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4922832
• MDR Text Key: 6026805
• Report Number: 2953769-2015-00101
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Catalogue Number: C01A
• Device Lot Number: EL35410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: BKP KIT
• Patient Outcome(s): Other