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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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MEDOS INTERNATIONAL SàRL CH EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 199721001
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 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 during an unknown procedure, the exp verse setscrews were prepared through turning back of the inner thread in order to prevent premature blocking of the rod.Although the screws were prepared, the inner and outer thread of the screws could not be fixated with a torque driver.The torque driver slipped through and wore off.The screw rod construct could be locked with another screw.The procedure was successfully completed without surgical delay.There was no patient consequence.The patient outcome was reported as good.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity unknown).This report is for one (1) expedium verse spine system unitized set screw 5.5.This is report 2 of 3 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: b5; d10: updated concomitant devices.D4: lot number; expiration date.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.B5; d1; d4; g1.
 
Event Description
Concomitant device reported: rod (part# unknown, lot# unknown, quantity unknown); screwdriver (part# unknown, lot# unknown, quantity unknown) this report is for one (1) expedium verse spine system verse correction key 5.5.
 
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: a product investigation was conducted.Visual inspection: the verse correction key (p/n: 199721000, lot #: avgbkz) was returned and received at us cq.Upon visual inspection, it was observed that the external threads of the rod lock component was deformed and stripped.The stripped condition of the external threads could have caused the complaint condition.No other issues were identified with the returned device.Dimensional inspection: a dimensional inspection was not performed on the returned device due to confirmed post manufacturing damage.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Expedium verse-dual lock assembly.Expedium verse- dual lock poly lock.Investigation conclusion: the complaint condition was confirmed for the verse correction key (p/n: 199721000, lot #: avgbkz) as the threads were stripped which could have caused the complaint condition.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.H3, h4, h6: a device history record (dhr) review was conducted: the dhr of product code: 199721000.Lot : avgbkz.Was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 25.05.2016.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 VERSE SPINE SYSTEM VERSE CORRECTION KEY 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 Key10919697
MDR Text Key218710154
Report Number1526439-2020-02307
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034466156
UDI-Public(01)10705034466156
Combination Product (y/n)N
PMA/PMN Number
PRE-AMEND
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 11/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number199721001
Device Catalogue Number199721000
Device Lot NumberAVGBKZ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2021
Date Manufacturer Received02/17/2021
Patient Sequence Number1
Treatment
5.5 EXP VERSE UNITIZED SET SCR; UNKNOWN ROD; UNKNOWN SCREWDRIVERS; UNKNOWN SCREWDRIVERS; 5.5 EXP VERSE UNITIZED SET SCR; UNKNOWN SCREWDRIVERS
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