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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRECISION SPINE, INC 5.5MM X 40MM POLYAXIAL SCREW LONG ARM; MNI, KWP, MNH
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PRECISION SPINE, INC 5.5MM X 40MM POLYAXIAL SCREW LONG ARM; MNI, KWP, MNH Back to Search Results
Catalog Number SLPL5540
Device Problems Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Information (3190)
Event Date 10/29/2014
Event Type  Injury  
Event Description
It was reported that during a procedure performed in (b)(6) on (b)(6) 2014, the tulip head of two 5.5mm x 40mm s-lok polyaxial screws splayed while torquing the locking caps.A piece of one of the screw threads detached during these attempts, fell into the patient's wound and had to be retrieved.The polyaxial screw was removed and replaced.A delay of 20 minutes occurred as a result of the reported issue.
 
Manufacturer Narrative
Device evaluation in process.A follow-up report will be submitted upon completion.
 
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Brand Name
5.5MM X 40MM POLYAXIAL SCREW LONG ARM
Type of Device
MNI, KWP, MNH
Manufacturer (Section D)
PRECISION SPINE, INC
pearl MS
Manufacturer Contact
2050 executive dr
pearl, MS 39047
6014204244
MDR Report Key4435883
MDR Text Key5393695
Report Number3005739886-2015-00004
Device Sequence Number1
Product Code MNI
Combination Product (y/n)N
Reporter Country CodeDR
PMA/PMN Number
K092128
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberSLPL5540
Device Lot Number8948PM
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/15/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received12/23/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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