MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER TI SAI POLY 8X80MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179704880
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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
It was reported that the primary surgery was performed on (b)(6) 2015 by using expedium plus spine system for sacroiliac joint.On (b)(6) 2018, the patient complained the pain at sacroiliac joint, so that the surgeon found that the reported screw was broken under x-ray (it was unknown when the breakage was occurred).It was reported that the only broken screw was explanted on (b)(6) 2018 from the patient¿s sacroiliac joint.No further information was provided by the hospital.
Additional Manufacturer Narrative
(b)(4).Returned device was sent for fracture analysis.The screw fracture surfaces image does not suggest fatigue fracture as characteristic fatigue striations are absent.The surfaces show highly irregularly shaped faces from either ductile failure and/or in vivo fretting.The bottom part of the shank displays apparent damage to the fracture surface and external threads consistent with tool marks inflicted during shank removal post fracture.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the post-operative breaking of the reported poly-axial screw cannot be determined.Fracture analysis of the screw suggests that surfaces show highly irregularly shaped faces from either ductile failure and/or in vivo fretting.Surfaces also display apparent damage to the fracture surface and external threads consistent with tool marks inflicted during shank removal post fracture.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: VIPER TI SAI POLY 8X80MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7864024
• Report Number: 1526439-2018-50858
• Device Sequence Number: 1720249
• Product Code: NKB
• UDI-Device Identifier: 10705034265728
• UDI-Public: (01)10705034265728
• Combination Product (Y/N): N
• PMA/510(K) Number: K111571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2018

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: Health Professional
• Device Model Number: 179704880
• Device Catalogue Number: 179704880
• Device Lot Number: TBIXT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR