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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH MIS SINGLE INNER SETSCW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH MIS SINGLE INNER SETSCW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 186715000
Device Problem Unstable Capture Threshold (3269)
Patient Problems Tissue Damage (2104); Blood Loss (2597); Not Applicable (3189)
Event Date 07/30/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). The mis single inner set screw was returned to the complaint handling unit (chu). The returned set screw features a variety of different witness marks, most of which are irregular witness marks. Typically, set screw witness marks are light, symmetrical marks on opposing sides of the bottom of the set screw that start as a sweeping scuff mark across its face and end in an indent. The returned set screw does not feature such markings. Although there are markings of some kind featured on the set screw, they vary significantly. All of the witness marks are some variation of shallow, asymmetrical, and irregular. The markings on the returned set screw is not indicative of the set screw correctly coming into contact with and being tightened down onto the associated rod. The set screw may have not been properly tightened down on top of the associated rod. This may have permitted the rod to migrate. A device history record review did not find any issues that caused or contributed to the reported event. All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting. The root cause of the set screws loosening could not be determined by the sample or information provided. A potential root cause may be the set screw not being correctly tightened down onto the rod properly. This may have allowed the rod to migrate. No issues could be identified in the manufacturing or release of these products. Therefore, this complaint 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.
 
Event Description
It was reported that the pedicle screw of l4 left couldn't stabilize the rod.
 
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Brand NameMIS SINGLE INNER SETSCW
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
Manufacturer (Section G)
MEDOS INT SPINE
chemin blanc 38
le locle
SZ
Manufacturer Contact
jason busch
325 paramount drive
raynham, MA 02767
5088808100
MDR Report Key7949078
MDR Text Key123195534
Report Number1526439-2018-50966
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K160904
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 08/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number186715000
Device Lot Number198019
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/28/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/09/2018 Patient Sequence Number: 1
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