MAUDE Adverse Event Report: PRECISION SPINE, INC. 5.5MM X 40MM POLYAXIAL SCREW LONG ARM

Catalog Number SLPL5540

Device Problems Fitting Problem (2183); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 02/12/2015

Event Type  Injury  

Event Description

It was reported that during a procedure performed in the (b)(6) on (b)(6) 2015, upon attempting to place final torque on the locking cap screw in the 5.5mm x 40mm polyaxial screw long arm, the tulip head splayed preventing secure seating of the locking cap screw.The polyaxial screw was removed and replaced resulting in a twenty (20) minute delay to the procedure.

Manufacturer Narrative

Device problem already known, no evaluation necessary.A trend for tulip head splay in the (b)(6) was previously identified and a capa was initiated for further investigation.Investigation identified that all complaints received reporting tulip head splay and inability to torque the locking screw received from the dominican republic illustrate failure of the system consistent with cross-threading.Training of the distributor and/or surgeons will be performed by a (b)(4) representative.

• Brand Name: 5.5MM X 40MM POLYAXIAL SCREW LONG ARM
• Manufacturer (Section D): PRECISION SPINE, INC.; pearl MS
• Manufacturer Contact: 2050 executive dr.; pearl, MS 39208 ; 6014204244
• MDR Report Key: 4589112
• MDR Text Key: 5337114
• Report Number: 3005739886-2015-00028
• Device Sequence Number: 1
• Product Code: MNI
• 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: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SLPL5540
• Device Lot Number: 3625PS
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2014
• 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