MAUDE Adverse Event Report: STRYKER SPINE-FRANCE FIXED ANGLE BONE SCREW DIAM 4.0 X 12MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number	48674012
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	04/22/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2016, the patient underwent the surgery.On (b)(6) 2016, the surgeon confirmed x-ray and found that the screw inserted in the bone is loosening.The surgeon is monitoring for the patient now.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment.Results: manufacturing records for this product were not reviewed because no lot numbers were provided as the parts remain implanted.The stryker rep was not able to obtain any additional information on this case due to hospital policy.X-rays were reviewed and exhibited a screw that had backed out of the plate.Conclusion: the possible root causes of this range from patient activity, poor bone quality and disease.However, the root cause is not determined and multifactorial due to lack of information obtained at the time of this report.
Event or Problem Description
It was reported that on (b)(6) 2016, the patient underwent the surgery.On (b)(6) 2016, the surgeon confirmed x-ray and found that the screw inserted in the bone is loosening.The surgeon is monitoring for the patient now.

• Brand Name: FIXED ANGLE BONE SCREW DIAM 4.0 X 12MM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5661430
• Report Number: 0009617544-2016-00193
• Device Sequence Number: 16196569
• Product Code: KWQ
• UDI-Device Identifier: 04546540392947
• UDI-Public: (01)04546540392947
• Combination Product (Y/N): N
• PMA/510(K) Number: K040261
• 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): 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48674012
• Device Lot Number: M9G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2016
• Supplement Report FDA Received Date: 07/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1