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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH EXPEDIUM SPINE SYSTEM SINGLE INNER SET SCREW 5.5; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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MEDOS INTERNATIONAL SàRL CH EXPEDIUM SPINE SYSTEM SINGLE INNER SET SCREW 5.5; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 179702000
Device Problem Migration (4003)
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 (b)(6) 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 single inner set screw 5.5.This is report 1 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 single-inner setscrew (part# 179702000, lot# 261035) 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 dhr of product code: 179702000, lot : 261035 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 13.11.2019.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.
 
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: single-inner setscrew (part# 179702000, lot# 261035, qty# 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that the bottom and top surfaces of the set screw show few scratches.Threads of the screw look good without any damage.Device failure/ defect was identified.Functional test: the received setscrew (179702000/ 261035) was assembled with rod (179772075/ tbdft7tr) and poly axial screw (179712645/ 262631) 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 single-inner setscrew (part# 179702000, lot# 261035) 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 dhr of product code: 179702000, lot : 261035, was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 13.11.2019 qty: (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.
 
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Brand Name
EXPEDIUM SPINE SYSTEM SINGLE INNER SET SCREW 5.5
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ  02400
MDR Report Key10869180
MDR Text Key217151738
Report Number1526439-2020-02242
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034064307
UDI-Public(01)10705034064307
Combination Product (y/n)N
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 10/26/2020
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 Model Number179702000
Device Catalogue Number179702000
Device Lot Number261035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2020
Date Manufacturer Received12/29/2020
Patient Sequence Number1
Treatment
MMSI ROD PREBENT, 5.5 X75MM, T; SI POLYAXL SCREW 6 X 45MM; UNK LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS; MMSI ROD PREBENT, 5.5 X75MM, T; SI POLYAXL SCREW 6 X 45MM; UNK LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS
Patient Outcome(s) Required Intervention;
Patient Age27 YR
Patient Weight130
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