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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); Injury (2348); Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
Visual examination at the macroscopic level revealed that the polyaxial screw fractured along the screw shank. The distal portion of the screw shank was not returned for analysis. Device was sent for fracture analysis which suggests fatigue first propagated along the progression line across the smooth surface region, then full failure / breakage occurred in the rough region at the termination site. 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 identified that the failure was indicative of fatigue. 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 the findings. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Revision of s1 left. For broken screw. When the surgeon went to remove the screw, the tip broke part of the shank is still in patient could not retrieve, placed a new screw in s2. Surgeon thinks original surgery was done in 2014.
 
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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 Key7009075
MDR Text Key179164668
Report Number1526439-2017-10955
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number179712740
Device Catalogue Number179712740
Device Lot NumberAJFBRV
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/08/2017 Patient Sequence Number: 1
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