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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC CONFIDENCE SPINAL CMT SYS, 11C; CEMENT, BONE, VERTEBROPLASTY
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DEPUY SPINE INC CONFIDENCE SPINAL CMT SYS, 11C; CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Model Number 283910000
Device Problems Migration or Expulsion of Device (1395); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/19/2021
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from india reports an event as follows: it was reported that on (b)(6) 2021 that the confidence cement was found to be defective during the surgery.There was not enough inside the hydraulic pump and was found to be leaking.Also, the quick connect did not attach to the reservoir cap.There was a forty (40) minute surgical delay.The procedure was completed successfully using another kit.This report is for one (1) confidence spinal cmt sys, 11c.This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h6: investigation summary.Photo investigation: the device was not returned for investigation.A photo investigation was performed on the image.The image attached was of the label of the confidence spinal cement system kit and does not include the picture of the kit.Hence, the complaint cannot be confirmed.A definitive root cause cannot be identified from the available information.The device history record review showed no non-conformances during manufacturing that could have contributed to this issue.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition cannot be confirmed based on the image provided.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.The dhr of product code: 283910000.Lot : 298310.Was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 02.02.2021.Qty: 48.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
CONFIDENCE SPINAL CMT SYS, 11C
Type of Device
CEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
MDR Report Key12188060
MDR Text Key262190987
Report Number1526439-2021-01427
Device Sequence Number1
Product Code NDN
UDI-Device Identifier10705034209623
UDI-Public10705034209623
Combination Product (y/n)N
PMA/PMN Number
K060300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 06/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number283910000
Device Catalogue Number283910000
Device Lot Number298310
Was Device Available for Evaluation? No
Date Manufacturer Received07/29/2021
Patient Sequence Number1
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