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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH 5.5 TI CORT FIX 5X45MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH 5.5 TI CORT FIX 5X45MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 186731545
Device Problem Disassembly (1168)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/16/2018
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
During screw insertion, surgeon used expedium quick connect polyaxial screwdriver t20 to remove and adjust the placement of screws a couple of time. The damage screw was discovered during the insertion of rod. The damaged screw has to be removed as it obstructed the placement of rod. Patient consequence? :unknown. Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
 
Manufacturer Narrative
Product complaint # (b)(4). Visual examination found no device failure. Swage markings were present indicative of the inner cap being properly placed in its intended position within the tulip head. Therefore, the reported device failure cannot be confirmed as no device failure was present during evaluation. 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. A root cause analysis is not required as there was no device failure noted during device evaluation. 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 Name5.5 TI CORT FIX 5X45MM
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 Key7496148
MDR Text Key108149165
Report Number1526439-2018-50460
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034351636
UDI-Public(01)10705034351636
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 04/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number186731545
Device Catalogue Number186731545
Device Lot NumberATKFC8
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2018
Is This a Reprocessed and Reused Single-Use Device? No

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