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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 Chemical Problem (2893)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 09/01/2020
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).The instrument(s) was not returned and instead the investigation is done based on the supplied image(s).The image(s) was reviewed and the complaint condition could be confirmed as the image provided shows the cement set in the tube.As the instrument(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Without a lot number the device history records review could not be completed.Product was not returned.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 there was failure of confidence spinal cement system during vertebroplasty surgery to treat a vertebral fracture reduction located at l2.The confidence kit in preparation is set almost immediately.There was a surgical delay of fifteen (15) minutes.Procedure was successfully completed.No further information provided.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: the dhr of product code: 283910000 lot : 273932 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: march 3, 2020 qty: (b)(4).Visual inspection: the confidence spinal cmt sys, 11 c (p/n: 283910000, lot #: 273932) was returned and received at us customer quality (cq).Upon visual inspection, only confidence pump assembly (p/n: 887014225) and the cement reservoir was returned from the kit.The cement was hardened inside the cement reservoir and there was some hardening liquid inside the pump.No other issues were identified with the returned device that could impact the device functionality.Functional test: the functional test was failed to perform on the returned device as the cement was solidified.However, when the molded handle was twisted to transfer the sterilized water through the connector, the sterilized water was being transferred to the proximal side of the confidence pump body above the piston tapered nut.Can the complaint be replicated with the returned device? unable to perform.Dimensional inspection: a dimensional inspection was not performed as the internal components of the pump and the connector were inaccessible without destruction of the device.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed: confidence, final packaging assembly; confidence cement reservoir and mixer kit; confidence pump assembly; confidence pump body assembly; confidence sub-assembly pump body; confidence elbow connector v3 body.Complaint confirmed? yes.Investigation conclusion: the complaint condition was confirmed for the confidence spinal cmt sys, 11 c (p/n: 283910000, lot #: 273932).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The possible cause could be the cement that may have solidified prematurely due to the manner with which it was stored and other environmental factors that might have an impact on the cement¿s setting time.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.The retained samples were tested in a temperature and humidity-controlled laboratory.In the testing of the retained samples for this lot number, the cement mixed and behaved as expected for the product type and met appropriate specifications.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.H10 additional narrative: h3, h6: the device was 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.
 
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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 Key10631152
MDR Text Key209960560
Report Number1526439-2020-01886
Device Sequence Number1
Product Code NDN
UDI-Device Identifier10705034209623
UDI-Public(01)10705034209623
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 09/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number283910000
Device Catalogue Number283910000
Device Lot Number273932
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2021
Date Manufacturer Received04/14/2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
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