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

Catalog Number SLPL6545

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.

Event Description

It was reported that the doctor was final tightening the set screw and the threads came out of the 6.5 mm x 45 mm polyaxial screw long arm (slpl6545).He tried another locking cap and rest of threads came out so the slpl6545 was removed and replaced a slp6545 6.5 mm x 45 mm s-lok polyaxial screw.There was a 10 minute delay as a result, but no harm to patient.

Event Description

It was reported that the doctor was final tightening the set screw and the threads came out of the 6.5mm x 45mm polyaxial screw long arm (slpl6545).He tried another locking cap and rest of threads came out so the slpl6545 was removed and replaced a slp6545 6.5mm x 45mm s-lok polyaxial screw.There was a 10 minute delay as a result, but no harm to patient.

Manufacturer Narrative

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.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 (b)(4) pieces of lot 10913ps were released for distribution on 1/9/2017 with no deviations or anomalies.Two-year complaint history review found this to be the only report for this lot.Further review did not identify a trend for reports of this nature for this part number.

• 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 Key: 7639273
• MDR Text Key: 112384017
• Report Number: 3005739886-2018-00004
• 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: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: SLPL6545
• Device Lot Number: 10913PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention