MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 7.5 X 45MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number 03821745

Device Problems Break (1069); Device Slipped (1584); Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 02/14/2017

Event Type  malfunction  

Event Description

It was reported that: cobalt chrome rod broken.Blockers loose at t10, t11, l4, l5, s1, iliac bolt and offset connector.Screw loose at left s1.Multiple levels of nonunion.Replaced rod and affected screws.

Manufacturer Narrative

Risk assessment; no product was returned and lot number was not provided, therefore device inspection, device history review and complaint history review could not be performed.Without the device inspection and further information the root cause cannot be determined conclusively.

Event Description

It was reported that: cobalt chrome rod broken.Blockers loose at t10, t11, l4, l5, s1, iliac bolt and offset connector.Screw loose at left s1.Multiple levels of nonunion.Replaced rod and affected screws.

• Brand Name: XIA LP POLYAXIAL SCREW 7.5 X 45MM
• Type of Device: SPINAL INTERVERTEBRAL BODY 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: 6408140
• MDR Text Key: 70314734
• Report Number: 3005525032-2017-00025
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 04546540149312
• UDI-Public: (01)04546540149312
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 03821745
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2017
• 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
• Patient Age: 62 YR
• Patient Weight: 127