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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH VIPER PRIME CFXFEN XTAB 7X45MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MEDOS INTERNATIONAL SàRL CH VIPER PRIME CFXFEN XTAB 7X45MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 186770445
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/04/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device is available for evaluation. Investigation will be conducted. Follow up will be filed with the investigation results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Viper prime t handle cracked and fell apart in surgeons hands whilst inserting 7 x 45 mm viper prime screw. Used same like product to complete putting in implant into patient. A separate viper prime screw did not insert into patient correctly. On closer examination, the screw seems loose in the cocr saddle. Used same like product to complete operation. Was surgery delayed due to the reported event?: yes. If yes, number of minutes: 5. Action taken when event occurred?: used same like products. Was procedure successfully completed?: yes. Were fragments generated?: no. If yes, were they removed easily without additional intervention?: yes. Patient status/ outcome / consequences: no. Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc. )?: n/a. Was other medical intervention (e. G. X-rays, additional procedures, prescriptions, otc, revision) required: unknown. Is the patient part of a clinical study: no. Ip-00629336: device property of: none. Device in possession of: none. Ip-00629337: device property of: none. Device in possession of: none. By checking this box i certify that all information that are known/available has been disclosed. If any new information will be made available, the additional information will be submitted through cst. : true.
 
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Brand NameVIPER PRIME CFXFEN XTAB 7X45MM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
DEPUY SYNTHES SPINE
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key8826484
MDR Text Key178377943
Report Number1526439-2019-51885
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034509617
UDI-Public(01)10705034509617
Combination Product (y/n)N
PMA/PMN Number
K170543
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number186770445
Device Catalogue Number186770445
Device Lot NumberTBVZD
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/2018
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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