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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXP 4.5 COCR ROD W/HEX 300; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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DEPUY SYNTHES SPINE EXP 4.5 COCR ROD W/HEX 300; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 186178300
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Spinal Column Injury (2081)
Date of Event 11/20/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
 
Event or Problem Description
I was called to provide removal instruments for expedium 4.5 due to the rods breaking.
 
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Brand Name
EXP 4.5 COCR ROD W/HEX 300
Common Device Name
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
DEPUY SYNTHES SPINE
325 paramount drive
raynham MA 02767
MDR Report Key7110179
Report Number1526439-2017-50067
Device Sequence Number10784516
Product Code NKB
UDI-Device Identifier10705034109541
UDI-Public10705034109541
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K090230
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number186178300
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/20/2017
Initial Report FDA Received Date12/12/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 Yes
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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