MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP MONOAXIAL SCREW 6.5 X 50MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 03820650

Device Problems Break (1069); Difficult to Remove (1528); Material Integrity Problem (2978)

Patient Problems Pain (1994); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Device Embedded In Tissue or Plaque (3165)

Event Date 04/28/2015

Event Type  Injury  

Event Description

It was reported that; a lawsuit was received from patient, reporting that the patient underwent lumbar arthrodesis surgery (l2, l3, l4, l5) in (b)(6) 2011 (codes not reported).He reports that after surgery he began to feel pain and, on (b)(6) 2015, he underwent an examination where it was found that one of the implanted screws was broken (l5).In (b)(6) 2015, he underwent revision surgery to remove the screw, which could not be fully extracted (the tip of the screw was housed in the l5 vertebral disc) and a bone graft was placed.Patient still reports pain and mobility issues.

Manufacturer Narrative

Lot# b03647.Method:device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Visual, dimensional and functional analysis could not be performed as the device was not returned.Conclusion: the root cause could not be determined.

Event Description

It was reported that; a lawsuit was received from patient, reporting that the patient underwent lumbar arthrodesis surgery (l2, l3, l4, l5) in (b)(6) 2011 (codes not reported).He reports that after surgery he began to feel pain and, on (b)(6) 2015, he underwent an examination where it was found that one of the implanted screws was broken (l5).In (b)(6) 2015, he underwent revision surgery to remove the screw, which could not be fully extracted (the tip of the screw was housed in the l5 vertebral disc) and a bone graft was placed.Patient still reports pain and mobility issues.

• Brand Name: XIA LP MONOAXIAL SCREW 6.5 X 50MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• 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: 6358182
• MDR Text Key: 68352626
• Report Number: 3005525032-2017-00019
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540148926
• UDI-Public: (01)04546540148926
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K060361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 03820650
• Device Lot Number: B03647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2010
• 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