MAUDE Adverse Event Report: DEPUY SYNTHES 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); Injury (2348)
Date of Event	04/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint investigation will be conducted 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
Breakage.Surgeon did posterior lumbar decompression and fusion operation on (b)(6) 2016.However, he found pain 2 months ago.And then he went to hospital on (b)(6) 2017 to have a check, it found the screw broke.The revision operation was taken on (b)(6) 2017.
Additional Manufacturer Narrative
The returned device was received with the shaft broken from the screw head.Optical imaging found two surface morphologies, a smooth and a grainy/rough region and progression lines which are indicative of fatigue failure.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 breaking cannot be positively determined.However, the fracture analysis report exhibits that two surface morphologies, a smooth and a grainy/rough region and progression lines which are indicative of 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; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6862776
• Report Number: 1526439-2017-10734
• Device Sequence Number: 788116
• 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
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2017

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: 179712740
• Device Catalogue Number: 179712740
• Device Lot Number: ARCC7N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Initial Date Received by Manufacturer: 08/18/2017
• Supplement Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 10/13/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR