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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE POLYAXIAL PEDICLE SCREW (ÿ 6.5 MM X 35 MM L)

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ZIMMER SPINE POLYAXIAL PEDICLE SCREW (ÿ 6.5 MM X 35 MM L) Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Report two of four for the same event; see also 0002184052-2016-00109, 00112 and 00113.
 
Event Description
Legal counsel reported a patient had two ¿harrington rods¿ that were implanted on (b)(6) 2009 to treat a back fracture.The original procedure was orif (open reduction internal fixation) with decompression l1 and bilateral posterolateral arthrodesis t11-l1 with pedicle screws.The patient alleges an x-ray taken on (b)(6) 2015 revealed the right rod had fractured.Patient further alleges pain and injuries to her neck, back, and ¿body as a whole.¿ it is unknown if a revision surgery has been performed.
 
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Brand Name
POLYAXIAL PEDICLE SCREW (ÿ 6.5 MM X 35 MM L)
Type of Device
SCREW
Manufacturer (Section D)
ZIMMER SPINE
7375 bush lake road
minneapolis MN 55439
Manufacturer (Section G)
ZIMMER SPINE
7375 bush lake road
minneapolis MN 55439
Manufacturer Contact
michelle cole
1520 tradeport drive
jacksonville, FL 32218
9047419468
MDR Report Key5761489
MDR Text Key48530690
Report Number0002184052-2016-00111
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK133086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Attorney
Type of Report Initial
Report Date 01/18/2016
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
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number8006535
Device Lot NumberUNKNOWN
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/18/2016
Initial Date FDA Received06/30/2016
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 Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age44 YR
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