MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA ROD TO ROD CLAMP - AXIAL; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	03805002
Medical Device Problem Codes	Mechanical Problem (1384); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	08/09/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; patient presented to the surgeon with pain following a fall.The previous case was performed on (b)(6) 2017 for pseudoarthorsis of l5-s1.The patient was revised using new screw with connectors.The rod pulled out from the right side and there is suspicion that the rod pulled out from the left side as well.The patient bone quality was average and the patient activity was moderate.Patient will undergo a revision surgery on (b)(6) 2017.This is the third revision surgery the patient will have.The other revision surgeries were not related to any instrumentation issues.
Additional Manufacturer Narrative
Results: visual, dimensional, functional, and material analysis could not be performed as the device was not returned.The construct was made such that there is multiple levels of fixation at the top, and multiple levels of fixation at the bottom, with a couple levels in between with no fixation where the connectors were used.This construct design with the existing curve of the spine allowed for a large bending moment to exist within the non fixed region, which can eventually cause the rod to slip out of the connector.Additionally, it was reported that the patient suffered a fall.The most likely root cause is multifactorial with the construct design and patient fall both contributing to the event.
Event or Problem Description
It was reported that; patient presented to the surgeon with pain following a fall.The previous case was performed on (b)(6) 2017 for pseudoarthorsis of l5-s1.The patient was revised using new screw with connectors.The rod pulled out from the right side and there is suspicion that the rod pulled out from the left side as well.The patient bone quality was average and the patient activity was moderate.Patient will undergo a revision surgery on (b)(6) 2017.This is the third revision surgery the patient will have.The other revision surgeries were not related to any instrumentation issues.

• Brand Name: XIA ROD TO ROD CLAMP - AXIAL
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6843609
• Report Number: 3005525032-2017-00090
• Device Sequence Number: 109016
• Product Code: KWQ
• UDI-Device Identifier: 04546540147998
• UDI-Public: (01)04546540147998
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2017

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 Model Number: 03805002
• Device Catalogue Number: 03805002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 12/28/2017
• 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
• Patient Age: 65 YR
• Patient Weight: 100