MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 TA6V LONG ROD DIAM 4.5 X 200; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48133200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported rod was broken post-operatively.As per the email communication with rep, the revision surgery was planned on (b)(6) 2018.
Additional Manufacturer Narrative
Methods: material analysis was performed and each rod was found to have fractured in bending fatigue as a result from the rod contact with another implant.Device history records were reviewed and all released units met specification.Elemental composition of the material confirms with the drawing.Results: the customer reported event was confirmed based on visual inspection of the returned devices.The elemental constituents were as specified on the print.No material or manufacturing defects were found.No similar complaints for the reported lot number were identified.Conclusion: the reported event occurred when the patient was putting backpack on their back.The plausible root cause is sudden impact leading to overload of the construct and assembly of construct producing large bending moment and loads on the device due severe deformity.The ifu state that, "the surgeon must warn the patient of the surgical risks and make aware of possible adverse effects.The surgeon must warn the patient that the device cannot and does not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implant can break or become damaged as a result of strenuous activity or trauma, and that the device may need to be replaced in the future.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) the surgeon must advise the patient that resultant forces can cause failure of the device.".
Event or Problem Description
Physician reported rod was broken post-operatively.The reported event occurred when the patient was putting backpack on their back.The device was explanted in a revision surgery.

• Brand Name: XIA TITANIUM 4.5 TA6V LONG ROD DIAM 4.5 X 200
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8178557
• Report Number: 0009617544-2018-00301
• Device Sequence Number: 11037322
• Product Code: NKB
• UDI-Device Identifier: 04546540449405
• UDI-Public: 04546540449405
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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: Health Professional
• Device Catalogue Number: 48133200
• Device Lot Number: M4R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 04/19/2019
• 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: 8 YR