MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 7.5X40MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 482802740

Device Problems Break (1069); Detachment Of Device Component (1104); Material Separation (1562); Material Integrity Problem (2978)

Patient Problems Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2017

Event Type  malfunction  

Event Description

It was reported that; this event occurred at the fixation of the l4/5 and the iliac bone of the pelvic fracture.When the final tightening of the blocker at right l4 screw, the surgeon confirmed that the screw head was came off from the screw shaft.After that, the surgeon pulled out the rod and confirmed that the screw of the l5 and iliac bone which was already implanted.The two screw heads were came off from the screw shaft too.Therefore, the three screws were exchanged the new other size screws and the operation was succeeded.

Manufacturer Narrative

Visual inspection; device history review; complaint history review; risk assessment.No relevant manufacturing issues were identified as all units met specifications.The screw was returned in 2 pieces, the tulip head was disengaged from the main screw body.It is likely that the reported event of tulip separation took place due to excessive force applied in an incorrect location on the screw.

Event Description

It was reported that; this event occurred at the fixation of the l4/5 and the iliac bone of the pelvic fracture.When the final tightening of the blocker at right l4 screw, the surgeon confirmed that the screw head was came off from the screw shaft.After that, the surgeon pulled out the rod and confirmed that the screw of the l5 and iliac bone which was already implanted.The two screw heads were came off from the screw shaft too.Therefore, the three screws were exchanged the new other size screws and the operation was succeeded.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X40MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6460630
• MDR Text Key: 72092168
• Report Number: 0009617544-2017-00130
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327002003
• UDI-Public: (01)07613327002003
• Combination Product (y/n): N
• PMA/PMN Number: K122845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 482802740
• Device Lot Number: 163621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/04/2016
• 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 Age: 22 YR