MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE CAN SCR 7.0X45; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 199725745S

Device Problems Break (1069); Device Slipped (1584)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that a postoperative follow-up examination revealed loosening of the screw (l4) on an unknown date.The revision surgery was planned to replace the screw and expand the spinal fusion range.On (b)(6) 2021, fracture of the screw (l3) was also found during image confirmation before the revision surgery.The revision surgery on (b)(6) 2021, was completed successfully without any surgical delay.This was a tes (l3, l4) for the spinal tumor on (b)(6) 2021.The surgery was completed successfully without any surgical delay.No further information is available.Concomitant device reported.Unknown rod (part# unknown, lot# unknown, qty unknown) unknown set screw (part# unknown, lot# unknown, qty unknown) unknown cage (part# unknown, lot# unknown, qty 1) this complaint involves two (2) devices.This report is for (1) 5.5 exp verse can scr 7.0x45 this is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6- the dimensional inspection was not performed due to post manufacturing damage.The observed condition of 5.5 exp verse can scr 7.0x45 in the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed broken condition of the 5.5 exp verse can scr 7.0x45.While no definitive root cause could be determined, it is probable that the 5.5 exp verse can scr 7.0x45 was broken due to the application of unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.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.Device history lot = product code: 199725745s, lot number: 307035.A manufacturing record evaluation was performed for the finished device.Product code: 199725745s, lot number: 307035.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 04.05.2021.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.5 EXP VERSE CAN SCR 7.0X45
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12902969
• MDR Text Key: 286445336
• Report Number: 1526439-2021-02487
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034440934
• UDI-Public: (01)10705034440934
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 199725745S
• Device Lot Number: 307035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE CAN SCR 7.0X45; UNK - CAGE/SPACERS; UNK - LOCKING/SET SCREWS: EXPEDIUM VERSE; UNK - RODS: EXPEDIUM VERSE
• Patient Age: 66 YR
• Patient Sex: Male