MAUDE Adverse Event Report: PRECISION SPINE, INC 6.5MM X 45MM S-LOK POLYAXIAL SCREW LONG ARM

Catalog Number SLPL6545

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 06/02/2016

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 2 mdrs filed for the same event (reference 3005739886-2016-00032 & 00033).

Event Description

It was reported that during a procedure performed in the (b)(6) on (b)(6) 2016, after placement of the locking screw in two 6.5mm x 45mm long arm polyaxial screws (slpl6545), the surgeon applied torque to the cap screw and when the anti-torque wrench was removed the tulip of both screws was opened laterally and the cap screw came out.Both polyaxial screws were removed and replaced with slp6545 6.5mm x 45mm polyaxial screw long arm.There was a delay of 30 minutes as a result of the reported issue.

Manufacturer Narrative

Engineering evaluation notes the threads of both polyaxial screw are partially sheared off and severely damaged.The images of the lock screws are most informative in that they display wear around the outer edge of the rod contact surface and the upper thread contact surfaces exhibit no signs of wear.The lock screw images indicate that both lock screws were not making flush contact with the rods, and that they did not fully seat in the polyaxial screws.The lock screw marring patterns indicate that the rods were skewed relative to the poly-axial screw's tulip component during the tightening process and remained skewed throughout the tightening process.As the lock screws were rotated during tightening their bottom outer edge contacted the rod and the outer edge was marred as a result of the misaligned condition.The degree to which this misaligned condition existed is believed to have been substantial since the lack of marring on the lock screw upper threads.Potential causes for the observed condition include but are not limited to rod contouring / construct configuration issues, multiaxial mechanism is bound up and not functioning (tulip cannot rotate to attain proper alignment), the polyaxial tulip is levered on during final tightening to prevent proper alignment from being achieved.The polyaxial screws may have been at their full range of motion and may not have been able to rotate further to attain proper orientation to clamp the rod due to the rod contour.If the multi-axial mechanism was rigidly bound up in a fixed orientation this may have prevented attaining proper rod - tulip orientation.Compressing across screws during the final tightening or inadvertent levering during final tightening may also have prevented the proper alignment of components to occur.The cause for the thread damage appears to stem from a misaligned tulip-rod condition that existed and was not overcome during the tightening process.Review of manufacturing history records found a total of 99 pieces released for distribution on 6/7/2013 with no deviation or anomalies.A three-year complaint history review (1.1.2013 - 6.7.2016) did not find any previous reports of this nature for the reported lot.The exact root cause cannot be determined.No product no-conformance, manufacturing or design issue was identified.As the root cause appears to be technique related, the need for corrective action was not indicated.This report is number 1 of 2 mdrs filed for the same event (reference 3005739886-2016-00032-1 / 00033-1).

• Brand Name: 6.5MM X 45MM S-LOK POLYAXIAL SCREW LONG ARM
• Type of Device: POLYAXIAL SCREW
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: beth albert ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 5751260
• MDR Text Key: 48246506
• Report Number: 3005739886-2016-00032
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: DR
• PMA/PMN Number: K092128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: SLPL6545
• Device Lot Number: 8349PM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention