MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXPEDIUM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179712740
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is available for evaluation.Investigation will be conducted.Follow up will be filed with findings.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
While performing an extension of an existing spondylodesis, the screw head of an already implanted screw in s1 (left) broke after loosening the innie and rod and retracting the soft tissue at the implant location.This screw was implanted app.2 years ago.It is not clear or unknown whether the screw head was already partially broken before extension surgery.It is therefore believed that the event occurred perioperative.Since the particular vertebral bodies l5-s1 seemed to be fused, no further actions were taken, the screw shaft was left in s1 and the spondy extension was performed as planned.
Additional Manufacturer Narrative
Visual examination of the returned device found the screw fractured at the transition zone between shank sphere and shank body.Optical imaging suggests a fatigue fracture.No material defects or other abnormalities have been identified in the fracture analysis report.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause for the polyaxial screw fracturing cannot be positively determined.However, the fracture analysis report suggests a fatigue failure.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXPEDIUM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6935184
• Report Number: 1526439-2017-10818
• Device Sequence Number: 1142323
• Product Code: NKB
• UDI-Device Identifier: 10705034067896
• UDI-Public: (01)10705034067896
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2017

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: Physician
• Device Model Number: 179712740
• Device Catalogue Number: 179712740
• Device Lot Number: ALJBW3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 10/17/2017
• Patient Sequence Number: 1