MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 70MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	482318570
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon reviewed xrays of a previous patient who underwent a fusion on (b)(6) 2016.He noted that the head of the left iliac bolt screw has disengaged from the screw shaft which is still in the patient.Surgeon uses an osteotome to create a hole in the iliac wing and then under fluoroscopy proceeds to use a lenke probe to create a path for the screw.He then uses a pedicle feeler, a hemostat & a ruler to chose the screw length.He does not tap for iliac bolts.After putting pelvic bolts in bilaterally he does birds-eye views of each bolt to ensure they are in the wing.He then connects offset neutral short connectors with blockers.
Additional Manufacturer Narrative
Risk assessment; manufacturing records could not be reviewed because the lot # is unknown.The device was not returned for evaluation and the lot number of the device is unknown.The most likely cause of the customer reported event cannot be determined.
Event or Problem Description
It was reported that; surgeon reviewed xrays of a previous patient who underwent a fusion on (b)(6) 2016.He noted that the head of the left iliac bolt screw has disengaged from the screw shaft which is still in the patient.Surgeon uses an osteotome to create a hole in the iliac wing and then under fluoroscopy proceeds to use a lenke probe to create a path for the screw.He then uses a pedicle feeler, a hemostat & a ruler to chose the screw length.He does not tap for iliac bolts.After putting pelvic bolts in bilaterally he does birds-eye views of each bolt to ensure they are in the wing.He then connects offset neutral short connectors with blockers.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 70MM
• 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: 6100728
• Report Number: 3005525032-2016-00144
• Device Sequence Number: 509849
• Product Code: KWP
• UDI-Device Identifier: 04546540598646
• UDI-Public: (01)04546540598646
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K083393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 482318570
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2016
• Supplement Report FDA Received Date: 01/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1