MAUDE Adverse Event Report: PRECISION SPINE, INC 6.5MM X 35MM POLYAXIAL SCREW LONG ARM

Catalog Number SLPL6535

Device Problems Break (1069); Positioning Problem (3009); Noise, Audible (3273)

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

Event Date 01/11/2017

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 1 of 2 mdrs filed for the same event (reference 3005739886-2017-00011/ 00012).Evaluation in process, not yet complete.

Event Description

During a procedure performed on (b)(6) 2017 in (b)(6), after placing 16 pedicle screws, rods and caps he started applying final torque.On the left side all locking screws were final tightened without issue.When applying torque on the 2nd screw on the right side, 6.5mm x 35mm polyaxial screw long arm, a sound produced by the locking screw in the tulip indicated a problem.After removal of the locking screw, stripping was visible on the screw head and threads of the pedicle screw.This screw was removed and replaced with a 6.5mm x 40mm polyaxial screw long arm and the locking screw was inserted and final torque applied without further issue.Upon applying torque to the third right-side 6.5mm x 35mm polyaxial screw long arm screw, incorrect position of the locking screw lead to stripping of the threads and failure of the locking mechanism.The locking screw was removed and the pedicle screw was left in place with the head unlocked.There was a 25 minute delay to the procedure due to the reported issue.

Manufacturer Narrative

Engineering evaluation noted damage to the lock screw's bottom thread od and the polyaxial screw's threads are sheared off or are deformed with marring on the id of the thread present.It is not clear if the counter torque wrench was being used during rod reduction.It is suspected that the counter torque wrench was not in used since the exterior of the polyaxial screw was in pristine condition while the thread experienced gross damage.It is suspected that the lock screw may have jumped a thread and became cross threaded due to the loading conditions applied when a counter torque wrench was not in position on the subject polyaxial screw.Review of manufacturing history records found (b)(4) pieces of this lot were released for distribution on 9/26/2014 with no deviation or anomalies.Four-year complaint history review found this to be the first report of this nature for the reported lot.No corrective actions are being recommended at this time since the failure is suspected to be technique related during a complex deformity procedure.This report is number 1 of 2 mdrs filed for the same event (reference 3005739886-2015-00011-1 / 00012-1).

• Brand Name: 6.5MM X 35MM 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 dr; pearl, MS 39208 ; 6014204244
• MDR Report Key: 6396910
• MDR Text Key: 69648837
• Report Number: 3005739886-2017-00011
• 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: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: SLPL6535
• Device Lot Number: 4936PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2014
• 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