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

Catalog Number	03820650
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/28/2015
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6358182
• Report Number: 3005525032-2017-00019
• Device Sequence Number: 18841845
• Product Code: NKB
• UDI-Device Identifier: 04546540148926
• UDI-Public: (01)04546540148926
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 03820650
• Device Lot Number: B03647
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2017
• Supplement Report FDA Received Date: 04/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention