MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 5.5 X 45MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	03821545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); No Information (3190)
Date of Event	05/30/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the screw was broken.
Additional Manufacturer Narrative
Catalog# 03821545.Lot# b25470.Pma/510(k)# k060361.The device is still implanted so it was not returned.Design history review was performed.No manufacturing issues identified.The ifu states that implanted devices may fatigue as they are not meant to indefinitely withstand the normal loads of bone and are only meant to aid in support during fusion of the vertebrae.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 advice the patient that resultant forces can cause failure of the device." without the device and further information regarding the patient, the root cause cannot be determined conclusively and is multifactorial.
Event or Problem Description
It was reported that the screw was broken.

• Brand Name: XIA LP POLYAXIAL SCREW 5.5 X 45MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 5934188
• Report Number: 3005525032-2016-00108
• Device Sequence Number: 16275980
• Product Code: KWP
• UDI-Device Identifier: 04546540148919
• UDI-Public: (01)04546540148919
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2016

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: 03821545
• Device Lot Number: B25470
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2016
• Supplement Report FDA Received Date: 11/22/2016
• 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: Other
• Patient Age: 66 YR