MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 40 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482316540
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/14/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; revision case of a broken screw.Patient was 6'2" 280lbs.Had 2 screws in patient on the leftside l4-l5.The screw in l4 broke.Patient was not harmed but had to have surgery to take broken piece out.The piece will be sent back to you.The doctor left the second half of the screw in the patients he said it would be more harmful to take it out.
Additional Manufacturer Narrative
Results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.During visual inspection the screw was inspected and it was confirmed it was fractured at the main thread body.Surgical technique states, if the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) the surgeon must advice the patient that resultant forces can cause failure of the device." the communication with the sales representative suggested that the patient does a lot of hunting activity.This might cause excessive stress on the implant which could lead to implant fracture.Conclusion: the possible root cause of the event might be patients failure to adhere to surgeons instruction regarding activity level post surgery.
Event or Problem Description
It was reported that; revision case of a broken screw.Patient was (b)(6).Had 2 screws in patient on the leftside l4-l5.The screw in l4 broke.Patient was not harmed but had to have surgery to take broken piece out.The piece will be sent back to you.The doctor left the second half of the screw in the patients he said it would be more harmful to take it out.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 40 MM
• 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: 5780593
• Report Number: 3005525032-2016-00081
• Device Sequence Number: 16300230
• Product Code: MNH
• UDI-Device Identifier: 04546540562234
• UDI-Public: (01)04546540562234
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2016

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: 482316540
• Device Lot Number: B41135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2016
• Supplement Report FDA Received Date: 09/26/2016
• 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: 127