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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SPINE SYSTEM PRE-BENT SPINAL ROD 5.5 X 75MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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DEPUY SPINE INC EXPEDIUM SPINE SYSTEM PRE-BENT SPINAL ROD 5.5 X 75MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 179772075
Device Problem Unintended Movement (3026)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.(b)(4).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 australia as follows: it was reported that on an unknown date, the set screw from the right l4 screw ¿popped-off¿ during an unknown procedure.Revision surgery was required.The surgeon removed the remaining two set screws at l5/s1, rod, and l4 screw.No further information was provided.Concomitant device reported: unknown screws (part# unknown, lot# unknown, quantity unknown ).Unknown rods (part# unknown, lot# unknown, quantity unknown ).This report is for one (1) expedium spine system pre-bent spinal rod 5.5 x 75mm.This is report 3 of 5 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.H3, h4, h6: the complaint cannot be confirmed for mmsi rod prebent, 5.5 x75mm, t (part# 179772075, lot# tbdft7tr) as no functional defect was evident with the returned device.A definitive root cause could not be determined for the reported problem.No product design or manufacturing issues were identified, and no new malfunctions were identified either.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 history lot = the possible root cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required.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.H3, h6: investigation summary: investigation flow: functional / damage.Visual inspection: mmsi rod prebent, 5.5 x75mm, t (part# 179772075, lot# tbdft7tr, qty# 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that there are scratches all over surface of the rod.The rod doesn¿t show any damage which would impact the functionality of the device.Device failure/ defect was identified.Functional test: the received rod (179772075/ tbdft7tr) was assembled with poly axial screw (179712645/ 262631) and setscrew (179702000/ 261035) with no issues.The assembly construct was tight as intended.The complaint can not be replicated with the returned devices.Document/ specification review: no design issues or discrepancies were noted during the investigation.Complaint was not confirmed.Investigation conclusion: the complaint cannot be confirmed for mmsi rod prebent, 5.5 x75mm, t (part# 179772075, lot# tbdft7tr) as no functional defect was evident with the returned device.A definitive root cause could not be determined for the reported problem.No product design or manufacturing issues were identified, and no new malfunctions were identified either.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 history lot: the possible root cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required.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
EXPEDIUM SPINE SYSTEM PRE-BENT SPINAL ROD 5.5 X 75MM
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
MDR Report Key10869194
MDR Text Key218524537
Report Number1526439-2020-02244
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034077963
UDI-Public(01)10705034077963
Combination Product (y/n)N
PMA/PMN Number
K131802
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 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number179772075
Device Lot NumberTBDFT7TR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2020
Date Manufacturer Received12/29/2020
Patient Sequence Number1
Treatment
SI POLYAXL SCREW 6 X 45MM; SINGLE-INNER SETSCREW; UNK LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS
Patient Outcome(s) Required Intervention;
Patient Age27 YR
Patient Weight130
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