MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP 6.35 TI POLY 7 X 50MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179912750
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
Date of Event	12/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation 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 patient went to clinic for routine post operative follow up and complained of "hip pain".An x-ray was performed and left s-1 screw was found to be fractured.The clinic notes states that the fractured screw is not likely the cause of the patient's pain.(patient had revision surgery on (b)(6) 2018 for a previous fusion surgery resulting in non-union (non-depuy hardware).The patient was exposed to 4 hours of anesthesia.Construct was performed with expedium 6.35 polyaxial screws and rods at l3-s1.Malfunction: device breakage.
Additional Manufacturer Narrative
(b)(4).Visual examination at the macroscopic level found that the polyaxial screw shank had fractured.The broken screw shank was not returned for evaluation.The fracture analysis exhibits two surface morphologies, a smooth region and a grainy/rough region with 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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the polyaxial screw shank fracturing cannot be positively determined.However, the fracture analysis report exhibits two surface morphologies, a smooth region and a grainy/rough region with 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: EXP 6.35 TI POLY 7 X 50MM
• 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: 7865867
• Report Number: 1526439-2018-50874
• Device Sequence Number: 11247803
• Product Code: NKB
• UDI-Device Identifier: 10705034086651
• UDI-Public: (01)10705034086651
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2018

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: 179912750
• Device Catalogue Number: 179912750
• Device Lot Number: ATFBFC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 09/26/2018
• 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: 63 YR
• Patient Weight: 80