MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 5.5 X 45MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	03821545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; screws implanted in 2007 broke on both sidesaddle s1 at about the same place.They were 5.5 x45.All hardware was removed and nothing was replaced.Patient was fused at l5 - s1.
Additional Manufacturer Narrative
Method: risk assessment; result: the device was not returned.Design history review could not be performed due to no lot numbers available.An overweight or obese patient can produce loads on the spinal system which can lead to failure of the fixation of the device or to failure of the device itself.Obesity is defined according to the w.H.O.Standards." it was calculated that the patient activity level is high (obese).Conclusion: the probable root cause of the reported event can be patient's high bmi.
Event or Problem Description
It was reported that; screws implanted in 2007 broke on both sidesaddle s1 at about the same place.They were 5.5 x45.All hardware was removed and nothing was replaced.Patient was fused at l5 - s1.

• Brand Name: XIA LP POLYAXIAL SCREW 5.5 X 45MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 5966017
• Report Number: 3005525032-2016-00113
• Device Sequence Number: 71728
• Product Code: NKB
• UDI-Device Identifier: 04546540149183
• UDI-Public: (01)04546540149183
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2016

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: 03821545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/21/2016
• Supplement Report FDA Received Date: 11/23/2016
• 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 Weight: 90