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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 Problem Migration or Expulsion of Device (1395)
Patient Problems Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Non-union Bone Fracture (2369); Osteopenia/ Osteoporosis (2651); Fluid Discharge (2686); Foreign Body In Patient (2687)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). 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. Investigation summary: product was not returned. Based on the information available, it has been determined that no corrective and 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 synthes (b)(6) reports an event in (b)(6) as follows: it was reported that the cement (confidence & vertecem) leaked into patient lung and cause clotting. It is unknown if the patient experience a post-op device malfunction, infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing. Patient status/ outcome/consequences are unknown. This complaint involves one (1) device. This report is for one (1) confidence spinal cmt sys, 11c. This report is 1 of 1 for (b)(4).
 
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Brand NameCONFIDENCE SPINAL CMT SYS, 11C
Type of DeviceCEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
BRIDGEWATER DISTRIBUTION
50 scotland boulevard
bridgewater MA 02324
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 
6103142063
MDR Report Key11576744
MDR Text Key242783390
Report Number1526439-2021-00575
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K060300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number283910000
Device Catalogue Number283910000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unkown

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