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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USASCREW

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SYNTHES USA SCREW   Back to Search Results
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

Additional narrative: investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided. Manufacturing records could not be reviewed without a lot number.

 
Event Description

An (b)(4) patient with neck pain greater than one year was treated with anti-inflammatories and physical therapy. Patient underwent x-rays on (b)(6) 2003 and was treated with fusion at c6-c7 with an acdf plate and four screws on (b)(6) 2003. Patient underwent cervical epidural steroid at c7-t1 for shoulder pain and radiating arm pain on (b)(6) 2004 and again on (b)(6) 2004. A ct scan on an unknown date showed fusion failure and pseudoarthrosis. Patient underwent a reconstruction procedure with allograft on (b)(6) 2004 without removal of implants. Patient presented sometime in 2011 with substantial trigger point discomfort right at the paraspinous muscle of the second level of the trapezius and underwent a facet rhizotomy. Patient then developed neck pain with upper extremity pain. Emg showed c6 radiculopathy. Mri showed ddd, hnp at c5-c6 with solid fusion at c6-c7. Patient was returned to the or on (b)(6) 2012 for removal of the cslp plate at c6-c7. Patient was treated with anterior c5-c6 biological spacer with allosource cortical cancellous graft, cervical interbody arthrodesis and anterior cervical plate fixation spanning c5-c6. This report is #2 of 5 for the same event.

 
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Brand NameSCREW
Type of DeviceSCREW
Manufacturer (Section F)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
jodi temple
1302 wrights lane east
west chester , PA 19380
(800) 620 -7025
Device Event Key2833746
MDR Report Key2805910
Event Key2702506
Report Number2520274-2012-02708
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 09/28/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/26/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Device Age
Was The Report Sent To Manufacturer? No
Date Manufacturer Received09/28/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/26/2012 Patient Sequence Number: 1
#TreatmentTreatment Date
PLATE, SCREWS
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