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

Model Number	179712045
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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
After implanting the screw, the surgeon removed a loose piece of a screw.It was the ¿u¿ shaped piece inside the polyaxial head of the screw.He removed the screw and replaced it with another one of the same size.
Additional Manufacturer Narrative
Udi: (b)(4).One (1) expedium 5.5 ti top loading 7.5x45mm polyaxial screw [product code: 1797-12-045] was returned to the customer quality unit (cqu) for evaluation.Visual examination found that the polyaxial¿s tulip head inner cap had become rotated out of position.No damage was present on the polyaxial screw shank.Swage markings were present indicative of the inner cap being properly placed in its intended position within the tulip head.As a result, it is suggested that unanticipated high amount of forces was placed on the tulip head resulting in the inner cap becoming rotated out of position.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.No emerging trends were found requiring further actions.A definitive root cause for the polyaxial¿s tulip head inner cap becoming rotated out of position cannot be positively determined.However, visual observation suggests that unanticipated high amount of forces was placed on the tulip head resulting in the inner cap becoming rotated out of position.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 requiring immediate action 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
• 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: 6984558
• Report Number: 1526439-2017-10929
• Device Sequence Number: 11042173
• Product Code: NKB
• UDI-Device Identifier: 10705034066592
• UDI-Public: (01)10705034066592
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2017

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: 179712045
• Device Catalogue Number: 179712045
• Device Lot Number: ATDCPD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 11/16/2017
• Patient Sequence Number: 1