MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 5.5 X 50MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	482316540
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; the doctor reported to sales rep that two out of four implanted screws had been found broken after 2 years from the initial surgery - (b)(6) 2015.A revision surgery is scheduled within 2 weeks.
Additional Manufacturer Narrative
Catalog# 03821550, lot# b46059.
Event or Problem Description
It was reported that; the doctor reported to sales rep that two out of four implanted screws had been found broken after 2 years from the initial surgery - (b)(6) 2015.A revision surgery is scheduled within 2 weeks.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: the device was inspected and it was found returned in 2 pieces.The screw had fractured at the thread body.No relevant manufacturing issues were identified as all units met stryker specifications.Conclusion: the root cause of the event is determined to be fatigue fracture due to falling of the patient.
Event or Problem Description
It was reported that; the doctor reported to sales rep that two out of four implanted screws had been found broken after 2 years from the initial surgery - (b)(6) 2015.A revision surgery is scheduled within 2 weeks.

• Brand Name: XIA LP POLYAXIAL SCREW 5.5 X 50MM
• 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: 6613085
• Report Number: 3005525032-2017-00064
• Device Sequence Number: 91524
• Product Code: KWP
• UDI-Device Identifier: 04546540562234
• UDI-Public: (01)04546540562234
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2017

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 Model Number: 482316540
• Device Catalogue Number: 03821550
• Device Lot Number: B46059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: Not provided; 05/10/2017
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 06/22/2017; 07/28/2017
• 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