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

Catalog Number 482318570

Device Problems Disassembly (1168); Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2016

Event Type  malfunction  

Event 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.

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 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
• Type of Device: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6100728
• MDR Text Key: 60428174
• Report Number: 3005525032-2016-00144
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 04546540598646
• UDI-Public: (01)04546540598646
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 482318570
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1