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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRECISION SPINE, INC 6.5MM X 45MM POLYAXIAL SCREW LONG ARM
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PRECISION SPINE, INC 6.5MM X 45MM POLYAXIAL SCREW LONG ARM Back to Search Results
Catalog Number SLPL6545
Device Problems Break (1069); Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2018
Event Type  Injury  
Manufacturer Narrative
Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.This report is number 1 of 3 mdrs filed for the same event (reference 3005739886-2018-00011 / 00013).
 
Event Description
It was reported that while the surgeon used the anti-torque device, the locking cap did not lock into three of the slplxxxx polyaxial long arm screws.Upon checking, it was discovered that the threading was gone on one side and broken on the other of the polyaxial screws so they were removed and replaced.No delay to the procedure or patient injury was reported.
 
Manufacturer Narrative
Device evaluation - the parts in the complaint appear to be representative of parts that are missing the partial thread.The root cause of the missing full thread on the slpl tulips has been attributed to the tooling off-set was not properly touched off after a tooling change for the 45 degree id tool.The lack of zeroing the tool properly resulted in the visible reduction of the thread width and the loss of the square shape of the full thread.Corrective actions have been initiated.Review of manufacturing history record found 25 pieces of lot 10913ps were released for distribution on 1/9/2017 with no deviations or anomalies.Two-year compliant history review found four (4) previous reports of this nature for the reported lot number.This report is number 1 of 3 mdrs filed for the same event (reference 3005739886-2018-00011-1 / 00013-1).
 
Event Description
It was reported that while the surgeon used the anti-torque device, the locking cap did not lock into three of the slplxxxx polyaxial long arm screws.Upon checking, it was discovered that the threading was gone on one side and broken on the other of the polyaxial screws so they were removed and replaced.No delay to the procedure or patient injury was reported.
 
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Brand Name
6.5MM X 45MM POLYAXIAL SCREW LONG ARM
Type of Device
POLYAXIAL SCREW
Manufacturer (Section D)
PRECISION SPINE, INC
2050 executive drive
pearl MS 39208
MDR Report Key7645580
MDR Text Key112581783
Report Number3005739886-2018-00011
Device Sequence Number1
Product Code MNH
Combination Product (y/n)N
PMA/PMN Number
K092128
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue NumberSLPL6545
Device Lot Number10913PS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2018
Was the Report Sent to FDA? No
Date Manufacturer Received01/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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