MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE EXPEDIUM 5.5 POLYAXIAL FAVORED ANGLE SCREW, 6.0 MM X 45 MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179799645
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Review of the device history record identified no issues during the manufacturing or release of the product that could be attributed to the problem reported by the customer.The product was released accomplishing all quality requirements.A follow up report will be filed upon completion of the investigation.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
The screw had to be explanted during revision surgery.When the surgeon tried to align the head of the screw with the head adjuster the inner parts of the screw head got loose and it made great difficulties to remove the screw.
Additional Manufacturer Narrative
The expedium 5.5 di favored angle ext.Tab 6mm polyaxial screw was returned for evaluation.Visual inspection revealed that the cap had rotated approximately 25 degrees from its intended location.Review of the device history record identified no issues during the manufacturing or release of the product that could have contributed to the problem reported by the customer.The product was released accomplishing all quality requirements.A review of the complaint trend analysis was performed and no systemic trend was identified as a result of the analysis.The root cause cannot be positively determined however the noted damage suggests that the screw may have been subjected to higher than anticipated force.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 have been observed, 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 5.5 POLYAXIAL FAVORED ANGLE SCREW, 6.0 MM X 45 MM
• 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: 6745004
• Report Number: 1526439-2017-10612
• Device Sequence Number: 881334
• Product Code: NKB
• UDI-Device Identifier: 10705034083650
• UDI-Public: (01)10705034083650
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 07/04/2017

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: 179799645
• Device Catalogue Number: 179799645
• Device Lot Number: ANDBL9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Initial Date Received by Manufacturer: 07/04/2017
• Supplement Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 08/09/2017
• Patient Sequence Number: 1