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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXPEDIUM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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DEPUY SYNTHES SPINE EXPEDIUM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 179712740
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Event Date 09/07/2017
Event Type  malfunction  
Manufacturer Narrative
Visual examination of the returned device found the screw fractured at the transition zone between shank sphere and shank body. Optical imaging suggests a fatigue fracture. No material defects or other abnormalities have been identified in the fracture analysis report. 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. A trend analysis was conducted. No emerging trends were found requiring further actions. A definitive root cause for the polyaxial screw fracturing cannot be positively determined. However, the fracture analysis report suggests a fatigue failure. 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.
 
Manufacturer Narrative
Device is available for evaluation. Investigation will be conducted. Follow up will be filed with findings. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
While performing an extension of an existing spondylodesis, the screw head of an already implanted screw in s1 (left) broke after loosening the innie and rod and retracting the soft tissue at the implant location. This screw was implanted app. 2 years ago. It is not clear or unknown whether the screw head was already partially broken before extension surgery. It is therefore believed that the event occurred perioperative. Since the particular vertebral bodies l5-s1 seemed to be fused, no further actions were taken, the screw shaft was left in s1 and the spondy extension was performed as planned.
 
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Brand NameEXPEDIUM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
DEPUY SYNTHES SPINE
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
MEDOS INTERNATIONAL SARL
325 paramount drive
raynham MA 02767
Manufacturer Contact
jason busch
325 paramount drive
raynham, MA 02767
5088808201
MDR Report Key6935184
MDR Text Key247420682
Report Number1526439-2017-10818
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160904
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number179712740
Device Catalogue Number179712740
Device Lot NumberALJBW3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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