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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC CONFIDENCE SPINAL CMT SYS, 11C; POLYMETHYLMETHACRYLATE BONE CEMENT
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DEPUY SPINE INC CONFIDENCE SPINAL CMT SYS, 11C; POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Model Number 283910000
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/20/2020
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that during a sacroplasty when the cement was applied a leakage occurred at the connection of the tube and the coupling to the cement reservoir.When the water reservoir was empty it was refilled with nacl solution.Once the refilling was finished, the cement was hardened.A second confidence system had to be used to finish the sacroplasty.There was a surgical delay of fifteen (15) minutes.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.Investigation summary: investigation flow: device interaction/functional.Visual inspection: the confidence spinal cmt sys, 11 c (p/n: 28910000, lot #: 262352) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the cement was hardened inside the cement reservoir and there was some hardening liquid inside the pump and reservoir.Cement was also found on the internal threads of the reservoir.No other issues were identified with the returned device.Functional test: the functional test was failed to perform on the returned device as the cement was solidified.Can the complaint be replicated with the returned device? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review based on the date of manufacture the following drawings, the current and manufactured revision of drawings were reviewed: confidence, final packaging assembly; confidence cement reservoir and mixer kit; confidence pump assembly.Complaint confirmed? yes.Investigation conclusion the complaint condition was confirmed for the confidence spinal cmt sys, 11 c.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to the cement reservoir might not have properly attached together during cement transfer and it may have caused the cement to leak.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the dhr of product code 283910000, lot 262352, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on november 28, 2019.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
POLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
MDR Report Key10112372
MDR Text Key194615442
Report Number1526439-2020-01104
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 05/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2020
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 Number262352
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2020
Date Manufacturer Received07/14/2020
Patient Sequence Number1
Patient Age61 YR
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