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

Model Number	179912645
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	09/01/2017
Type of Reportable Event	Serious Injury
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
Two set screws of two expedium universal connectors were loosened and one got totally off one month postoperatively after revision surgery (due to earlier broken rods).And one polyaxial screw head of one expedium 6.35 polyaxial screw got off when removing the screw with the corresponding screw driver.Rods will also be sent to investigation.What might have caused the loosening of the set screws? these products are also a part of this complaint: exp set screw 6.35, catalog 179902000, lot arbc68,1 ea, will be returned exp 6.35 screw poly 6.0x45, catalog 179902000, lot 133674, 2 ea, will be returned.
Additional Manufacturer Narrative
Visual examination of the returned device noted the screw¿s tulip head and saddle had completely separated from the screw shank.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.The root cause of the tulip head, saddle, and screw head separating cannot be determined from the samples and the information provided.A potential root cause may be excessive force placed on the polyaxial screw during tightening.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 VERSE
• 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: 6967819
• Report Number: 1526439-2017-10883
• Device Sequence Number: 16607232
• Product Code: NKB
• UDI-Device Identifier: 10705034086477
• UDI-Public: (01)10705034086477
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2017

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: Physician
• Device Model Number: 179912645
• Device Catalogue Number: 179912645
• Device Lot Number: ARDBDF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 10/22/2017
• Supplement Report FDA Received Date: 11/14/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention