MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 7.0X50; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number	199723750
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual examination found the external threads of the device were slightly worn.There was light discoloration along the shaft and head of the device.The reduction tabs were broken from the screw head however this is consistent with normal use of the device.The screw heads internal threads were completely broken from the screw head, no fragments were returned.The inner core of the screw head had shear marks from the broken internal threads.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.Although no definitive root-cause can be determined, it is possible the threads were damaged due to unintended forces during either implantation or explantation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.
Event or Problem Description
Two correction keys of expedium verse broke apart while tightening with torque limiting handle.Correction keys and screw were replaced with a new correction key and new screw.Delay of surgery was about 15min.Was surgery delayed due to the reported event?: unknown.Was procedure successfully completed?: unknown.Were fragments generated?: unknown.If yes, were they removed easily without additional intervention?: unknown.Patient status/ outcome / consequences: no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study: unknown.Ip-00762218 device property of: none.Device in possession of: none.Ip-00762219 device property of: none.Device in possession of: none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.Concomitant device reported: unknown torque limiting handle (part#: unknown, lot#: unknown, quantity: 1).This complaint involves three (3) devices.

• Brand Name: 5.5 EXP VERSE FEN SCR 7.0X50
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9563547
• Report Number: 1526439-2020-00251
• Device Sequence Number: 2223994
• Product Code: MNI
• UDI-Device Identifier: 10705034402901
• UDI-Public: 10705034402901
• Combination Product (Y/N): N
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 199723750
• Device Lot Number: 251989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1