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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES SPINE SINGLE INNER POLYAXIAL SCREW 5.5 X 6.00 X 50MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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DEPUY SYNTHES SPINE SINGLE INNER POLYAXIAL SCREW 5.5 X 6.00 X 50MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 179712650
Device Problems Break (1069); Defective Component (2292)
Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Injury (2348); Disability (2371)
Event Type  Injury  
Manufacturer Narrative

(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. Sample not returned for evaluation.

 
Event Description

Reported thru legal: on (b)(6) 2014, patient was required to have the defective, unsafe and/or undersized screws surgically removed by surgeon as the defective, unsafe and/or undersized screws had broken and completely failed. As a direct and proximate result of the dangerous, defective, unsafe, and/or undersized screws placed into patient's body, plaintiffs have suffered and will continue to suffer noneconomic loss including severe injury and disability, including physical and mental pain and suffering, and will continue to experience such injuries into the future.

 
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Brand NameSINGLE INNER POLYAXIAL SCREW 5.5 X 6.00 X 50MM
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
michael jacene
325 paramount drive
raynham, MA 02767
5089776485
MDR Report Key5401888
MDR Text Key37239787
Report Number1526439-2016-10098
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK111136
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 01/05/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/01/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue Number179712650
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received01/05/2016
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? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 02/01/2016 Patient Sequence Number: 1
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