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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH VIPER MONO SCREW 6X45MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH VIPER MONO SCREW 6X45MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 186717645
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
Additional device product codes: osh, mnh, kwp, mni, kwq.Part of the screw remained in the patient¿s bone; device not considered explanted.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) 2019 the patient underwent a pps to treat the traumatic injury.On (b)(6) 2021 x-rays were taken which revealed that two (2) screws had broken off in the centrum.On (b)(6) 2021 the patient underwent a revision procedure.The fragments were left in the patient's body.Other implants were successfully explanted.No further information is available.This report is for one (1) viper mono screw 6x45mm ti.This is report 1 of 2 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: h3, h6: a review of the receiving inspection (ri) for viper mono screw 6x45mm ti was conducted identifying that lot number rl261427 was released in a single batch.Batch1: lot qty of (b)(4) units were released on october 4, 2017 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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 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
VIPER MONO SCREW 6X45MM TI
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 Key11498851
MDR Text Key240599876
Report Number1526439-2021-00463
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034123479
UDI-Public(01)10705034123479
Combination Product (y/n)N
PMA/PMN Number
K160904
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number186717645
Device Catalogue Number186717645
Device Lot NumberRL261427
Initial Date Manufacturer Received 02/17/2021
Initial Date FDA Received03/16/2021
Supplement Dates Manufacturer Received04/16/2021
Supplement Dates FDA Received05/12/2021
Patient Sequence Number1
Treatment
UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; VIPER MONO SCREW 6X45MM TI
Patient Outcome(s) Required Intervention;
Patient Age72 YR
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