MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ILIOS XIA LP POLYAXIAL SCREW 7.5 X 100MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number	03821700
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	09/09/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a fractured screw in the pelvis was noticed 4 weeks post op.The construct is still holding up, no revision surgery planned, patient is not experiencing any complications.
Additional Manufacturer Narrative
Adverse event/product problem: serious injury.Date of explant: (b)(6) 2016.Type of reportable event: serious injury.
Event or Problem Description
It was reported that a fractured screw in the pelvis was noticed 4 weeks post op.The construct is still holding up, no revision surgery planned, patient is not experiencing any complications.
Additional Manufacturer Narrative
Method: risk assessment; results: device inspection, complaint review, manufacturing review and device history review was not performed because no parts were returned and no lot# provided.Conclusion: the definitive root cause of the event could not be determined from given information.
Event or Problem Description
It was reported that a fractured screw in the pelvis was noticed 4 weeks post op.The construct is still holding up, no revision surgery planned, patient is not experiencing any complications.

• Brand Name: ILIOS XIA LP POLYAXIAL SCREW 7.5 X 100MM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6148653
• Report Number: 3005525032-2016-00153
• Device Sequence Number: 710248
• Product Code: KWQ
• UDI-Device Identifier: 04546540433800
• UDI-Public: (01)04546540433800
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2017

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: 03821700
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/11/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/06/2016
• Supplement Report FDA Received Date: 12/09/2016; 06/06/2017
• 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: 12 YR