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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CH VIPER2 STRAIGHT ROD-120MM BONE-SCREW INTERNAL SPINAL FIXATION SYSTEM, NON-STERILE

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MEDOS INTERNATIONAL SARL CH VIPER2 STRAIGHT ROD-120MM BONE-SCREW INTERNAL SPINAL FIXATION SYSTEM, NON-STERILE Back to Search Results
Catalog Number 186789120S
Device Problem Device Slipped (1584)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/25/2022
Event Type  malfunction  
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. 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. Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received. 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.
 
Event Description
Device report from depuy synthes reports an event in germany as follows: it was reported by the affiliate sales rep customer in germany that during an unknown surgery on (b)(6) 2022, it was observed that the rod device immediately fell through the hole on the floor as it was passed. There were no adverse patient consequences nor surgical delay reported. No additional information was provided. This complaint involves one (1) device.
 
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Brand NameVIPER2 STRAIGHT ROD-120MM
Type of DeviceBONE-SCREW INTERNAL SPINAL FIXATION SYSTEM, NON-STERILE
Manufacturer (Section D)
MEDOS INTERNATIONAL SARL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
MEDOS INT SPINE
chemin blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kate karberg
chemin-blanc 38
le locle 02400
SZ   02400
3035526892
MDR Report Key14471147
MDR Text Key296223673
Report Number1526439-2022-00731
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K131802
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number186789120S
Device Lot NumberCSNACT
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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