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	09/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).Visual inspection of the returned device 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 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
A female patient, born (b)(6), was treated today ((b)(6) 2019) with the expedium verse adavanced set (orthokit, see screenshot of reservation) at l3-l4.When the correction cap was inserted, it was tilted in the long head of the expedium verse advanced screw so much that the long thread of two screws was defective and a total of 6 correction caps were defective.At the final tightening with torque of the inner adjusting screw in one situation the inner adjusting screw was so defective that it broke.Surgical delay about 1 hour, procedure was completed with modular end caps after they changed two screws.

• 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: 9383423
• Report Number: 1526439-2019-52514
• Device Sequence Number: 19260315
• Product Code: MNI
• UDI-Device Identifier: 10705034402901
• UDI-Public: 10705034402901
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2019

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 Catalogue Number: 199723750
• Device Lot Number: 244498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 90