MAUDE Adverse Event Report: PRECISION SPINE, INC 5.5MM X 45MM POLYAXIAL SCREW LONG ARM

Catalog Number SLPL5545

Device Problems Compatibility Problem (2960); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2017

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 2 of 3 mdrs filed for the same event (reference 3005739886-2018-00006 / 00008).

Event Description

It was reported that after placing the screws and locking caps, doctor proceeded to apply torque.When applying torque, the 5.5 mm x 45 mm polyaxial screw long arm showed a mismatch between the edge of the screw and the position of the cap.The whole system was removed, screws were replaced and torque was applied manually to surgeon preference.There was a 30 minute delay to the procedure as a result.No patient injury was reported.

Event Description

It was reported that after placing the screws and locking caps, doctor proceded to apply torque.When applying torque, the 6.5mm x 45mm polyaxial screw long arm showed a mismatch between the edge of the screw and the position of the cap.The whole system was removed, screws were replaced and torque was applied manually to surgeon preference.There was a 30 minute delay to the procedure as a result.No patient injury was reported.

Manufacturer Narrative

H3 product evaluation - 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 were initiated.A health hazard evaluation was performed to assess the risk of the identified non-conformance.It was determined that there was a none/negligible health risk to the patient.Review of manufacturing history record found 26 pieces of lot 12323ps were released for distribution on 1/4/2017 with no deviations or anomalies.Two-year complaint history review did not identify a trend for reports of this nature.This report is number 2 of 3 mdrs filed for the same event (reference 3005739886-2018-00006-1 / 00008-1).

• Brand Name: 5.5MM 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 Key: 7642850
• MDR Text Key: 112497574
• Report Number: 3005739886-2018-00007
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• PMA/PMN Number: K092128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: SLPL5545
• Device Lot Number: 12323PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention