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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC VERSE CORRECTION KEY; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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DEPUY SPINE INC VERSE CORRECTION KEY; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Model Number 199721000
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Additional product code: kwp;kwq;mnh;mni;osh.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.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
It was reported that on (b)(6) 2021, the patient underwent for scoliosis surgery using the expedium verse system.During the final tightening, the inner part of the correction keys kept stripping.The stripped correction keys were removed and replaced with unitized set screws.There was a surgical delay of twenty-five (25) minutes.There were no fragments generated.There were no patient consequences.The procedure was successfully completed.Concomitant device reported.Verse x25 inserter/tightener (part# 299704230, lot# unknown, qty 3).This complaint involves thirteen (13) devices.This report is for (1) verse correction key.This report is 10 of 13 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.A manufacturing record evaluation was performed for the finished device product code: 199721000; lot number: 277522; it was electronically reviewed and no non-conformance's / manufacturing irregularities were identified during the manufacturing process.The product was released on: march 20, 2020.Visual inspection: the verse correction key (part# 199721000, lot# 277522 qty# 1) was returned and received at us customer quality (cq).Upon visual inspection, it is observed that the hexlobe feature of the rod lock component was stripped.No other issues were found with the device.Device failure/defect identified? yes.Dimensional inspection: dimensional inspection of the relevant feature of the received device was not performed at cq due to post manufacturing damage.Document/specification review: the following drawings (current and manufactured to) were reviewed: expedium verse - dual lock assembly; expedium verse - dual lock rod lock; no design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: the complaint is being confirmed for the verse correction key (part# 199721000, lot# 277522 qty# 1).While a definitive root cause could not be identified for the reported issue from the available information, it is likely that the complaint condition was caused due to the use of the worn inserters to fasten the device.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, 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 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
VERSE CORRECTION KEY
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key13088230
MDR Text Key285047276
Report Number1526439-2021-02634
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034466132
UDI-Public10705034466132
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142185
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number199721000
Device Catalogue Number199721000
Device Lot Number277522
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/12/2022
Initial Date FDA Received12/27/2021
Supplement Dates Manufacturer Received01/12/2022
Supplement Dates FDA Received01/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/20/2020
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE X25 INSERTER/TIGHTENER; VERSE X25 INSERTER/TIGHTENER; VERSE X25 INSERTER/TIGHTENER
Patient Age15 YR
Patient SexMale
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