MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 5.5 X 40MM; PEDICLE SCREW SPINAL SYSTEM

Model Number	03821540
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	10/04/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; after five months of initial surgery, the patient related pain to surgeon.The screw was broken and a new procedure was scheduled to replace it.
Additional Manufacturer Narrative
Device history review; complaint history review; risk assessment.Visual, dimensional and functional analysis could not be performed as the device was not returned.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The definitive root cause of the event could not be determined from given information.
Event or Problem Description
It was reported that; after five months of initial surgery, the patient related pain to surgeon.The screw was broken and a new procedure was scheduled to replace it.

• Brand Name: XIA LP POLYAXIAL SCREW 5.5 X 40MM
• 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: 6530322
• Report Number: 3005525032-2017-00053
• Device Sequence Number: 18965505
• Product Code: NKB
• UDI-Device Identifier: 04546540149176
• UDI-Public: (01)04546540149176
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2017

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: 03821540
• Device Catalogue Number: 03821540
• Device Lot Number: B40396
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: 04/03/2017
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 07/20/2017
• 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: 39 YR
• Patient Weight: 77