MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL SCREW 7 X 50MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179712750
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Pc: surgical intervention and device removal.(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 a revision surgery necessary due to broken screws postoperative.Initial surgery on (b)(6) 2017 dorsal l3-l5.Revision surgery took place on (b)(6) 2019.Exact date when screw broke off is unknown.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Udi: (b)(4).The screw was found to have broken at the screw shank¿s neck.Fracture analysis was subsequently performed on the screw.Optical imaging of the fracture site shows two surface morphologies, a smooth region and a rough region with progression lines that are indicative of fatigue failure.This implies that the fracture initiated near one end and then propagated through the body of the shank across its axial plane to full failure/breakage near the opposing side, presumably when the strength of the remaining material was insufficient to bear the load.The images reveal fatigue striations/progression lines that extend across the surface toward the potential crack termination site.The surface also exhibits minor scratches and smooth shiny areas indicative of surfaces rubbing against one another 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.The root cause of the screw breaking cannot be determined from the sample and the information provided.The results of fracture analysis have determined that a potential root cause may be a 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, 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.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: SI POLYAXL SCREW 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: 8552395
• Report Number: 1526439-2019-51563
• Device Sequence Number: 18925863
• Product Code: NKB
• UDI-Device Identifier: 10705034067919
• UDI-Public: (01)10705034067919
• Combination Product (Y/N): N
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2019

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: 179712750
• Device Catalogue Number: 179712750
• Device Lot Number: 144132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 05/20/2019; 07/09/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 06/07/2019; 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 85