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U.S. Department of Health and Human Services

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

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DEPUY SYNTHES SPINE EXPEDIUM VERSE ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 199721525
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Spinal Column Injury (2081); Injury (2348); Paraplegia (2448)
Event Date 09/25/2017
Event Type  Injury  
Manufacturer Narrative
A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device not returned for evaluation.
 
Event Description
After surgery the patient woke up with very little feeling in their legs. Post-op ct was done and the surgeon identified four screws that had been placed medial. (left t3,t4,t6 and right t6) replacement. The patient was returned to the or and four screws were removed and the rods and correction keys were re-implanted.
 
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Brand NameEXPEDIUM VERSE
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
chemin blanc 38
le locle CH-24 00
SZ CH-2400
Manufacturer Contact
jason busch
325 paramount drive
raynham, MA 02767
5088808201
MDR Report Key6948941
MDR Text Key89354156
Report Number1526439-2017-10834
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034442488
UDI-Public(01)10705034442488
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142185
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number199721525
Device Catalogue Number199721525
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/13/2017 Patient Sequence Number: 1
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