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U.S. Department of Health and Human Services

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

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DEPUY-SYNTHES SPINE EXPEDIUM ROD ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number UNK ¿ SPINAL IMPLANT
Device Problem Insufficient Information (3190)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
Udi: unknown part number, udi is unavailable. 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.
 
Event Description
Notified by legal: patient was implanted with expedium hardware on (b)(6) 2016. Patient had persistent pain and "grinding" in his lower back post-op. The implants failed and were removed. No further details were provided.
 
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Brand NameEXPEDIUM ROD
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)
DEPUY-SYNTHES SPINE
325 paramount drive
raynham MA 02767
Manufacturer Contact
jason busch
325 paramount drive
raynham, MA 02767
5088808201
MDR Report Key6811394
MDR Text Key83268872
Report Number1526439-2017-10692
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial
Report Date 08/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK ¿ SPINAL IMPLANT
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2017
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: 08/22/2017 Patient Sequence Number: 1
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