MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW CLOSED HEAD 8.5 X 80MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Model Number	03820650
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: it is about a patient operated several times (we don't have the details on the various interventions this patient had), who has today a long assembly of posterior fixation with iliac extension and intersomatic cages.To my knowledge, the patient was asymptomatic, but prof spotted on the x-rays, presumably during a follow-up visit, that the right iliac screw had broken.During the revision surgery, prof removed the broken part of the screw (tulip) and changed the connector above, because he had to unscrew the bolts.The rest of the implant was not removed (impossible) and prof put a new iliac screw to mount the assembly again.The event was observed presumably on control images a few months after implantation (in (b)(6) 2017), the patient was doing well and prof was satisfied with the level of fusion.The revision surgery lasted about 40 minutes without x-rays.
Event or Problem Description
It was reported that: it is about a patient operated several times (we don't have the details on the various interventions this patient had), who has today a long assembly of posterior fixation with iliac extension and intersomatic cages.To my knowledge, the patient was asymptomatic, but prof spotted on the x-rays, presumably during a follow-up visit, that the right iliac screw had broken.Indeed, we can see on the attached pictures the net section between the tulip and the screw thread.During the revision surgery, prof removed the broken part of the screw (tulip) and changed the connector above, because he had to unscrew the bolts.The rest of the implant was not removed (impossible) and prof put a new iliac screw to mount the assembly again.The event was observed presumably on control images a few months after implantation (in april 2017), the patient was doing well and prof was satisfied with the level of fusion.The revision surgery lasted about 40 minutes without x-rays.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW CLOSED HEAD 8.5 X 80MM
• 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: 7163508
• Report Number: 3005525032-2018-00001
• Device Sequence Number: 1903128
• Product Code: KWP
• UDI-Device Identifier: 04546540148926
• UDI-Public: (01)04546540148926
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018

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 Model Number: 03820650
• Device Catalogue Number: 482378580
• Device Lot Number: B31912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Initial Date Received by Manufacturer: 12/09/2017
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 03/05/2018
• 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: 60 YR