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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; 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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a vertebral arthrodesis procedure with pedicle screw cementation.During the surgery, the system that pushes the cement into the cannula / screw (pump system with water) did not work properly due to the water leaking.It was not possible to cement all the screws of the implant.The surgery was completed successfully with 30 minutes delay reported.There were no patient consequences are reported.Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity unknown).This complaint involves two (2) devices.This report is for (1) confidence spinal cmt sys, 11c.This report is 2 of 2 (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.H10 additional narrative: h3, h4, h6- product complaint #
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> pc-(b)(4).Investigation summary
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> 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 history lot
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> the dhr of product code 283910000, lot 277108, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on april 6, 2020.The dhr was electronically reviewed.Device history batch
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> null device history review
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> null 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.The confidence spinal cmt sys, 11 c (p/n: 283910000, lot #: 277108) was returned and received at us cq.Upon visual inspection, only confidence pump assembly (p/n: 887014225), the cement reservoir was returned from the kit.Most of the water is inside the cement reservoir but some of the cement was solidified at the bottom.No other issues were identified with the returned device that could impact the device functionality.The complaint condition was confirmed for the confidence spinal cmt sys, 11 c (p/n: 283910000, lot #: 277108).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.Cement retest results were checked, and no concerns were observed with the testing results.Please refer to that attached investigation and retest results for complete retest results performed on the cement lot number.Device history lot: the dhr of product code 283910000, lot 277108, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on april 6, 2020.The dhr was electronically reviewed.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 Key11576639
MDR Text Key245541665
Report Number1526439-2021-00581
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 02/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2021
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 Number277108
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2021
Date Manufacturer Received08/06/2021
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Treatment
CONFIDENCE SPINAL CMT SYS, 11C; UNKNOWN SCREWS
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