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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH VIPER POLY SCREW 8X50MM TI ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH VIPER POLY SCREW 8X50MM TI ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 186715850
Device Problem Disassembly (1168)
Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Event Date 03/19/2018
Event Type  malfunction  
Manufacturer Narrative
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
It was reported doctor was implanting 8x50 viper screw. He stopped to take fluoro picture to confirm all was ok with placement. Started to advance screw further down and screw head popped off. The ring between screw head and screw shank was broken. Had to retrieve those broken metal fragments and take screw shaft out. Fifteen minutes delay reported.
 
Manufacturer Narrative
Product complaint # (b)(4). Visual examination of the viper poly screw 8 x 50mm ti revealed that the screw head was disassembled from the shank, with broken saddle intact in the screw head. A review of the device history record was conducted. No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer. All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting. The root cause of the screw falling apart intraoperatively cannot be determined from the sample and the information provided. A potential root cause may be inadvertent force placed on the drive feature of the screw during tightening, potentially at a significant angle, resulting in the screw disassembling during use. As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required. 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 NameVIPER POLY SCREW 8X50MM TI
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
MDR Report Key7432336
MDR Text Key106025995
Report Number1526439-2018-50358
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034122755
UDI-Public(01)10705034122755
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,health
Type of Report Initial,Followup
Report Date 03/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number186715850
Device Catalogue Number186715850
Device Lot NumberRL260178
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

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