MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 4.5 X 5.0 X 35MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number	186112535
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/30/2023
Type of Reportable Event	Serious Injury
Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2: additional procodes: kwq, kwp, nkb, mnh, osh.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 or Problem Description
Device report from chile reports an event as follows: it was reported that on (b)(6) 2023, the screws in question were removed from the patient.The nut was not placed on the screw, the screws were loose in the patient.The procedure was completed successfully with a surgical delay of approximately 1 hour.There were no adverse patient consequences.No further information is available.This report is for an expedium spine system polyaxial screw 4.5 x 5.0 x 35mm.This is report 1 of 2 for (b)(4).
Additional 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.H10 additional narrative: h4, h6: a review of the receiving inspection (ri) for exp 4.5 ti poly scw 5.00x35 was conducted identifying that lot number rl15713 was released in two batch.Batch 1: lot units were released on 26 sep 2012 with no discrepancies.Batch 1: lot units were released on 07 aug 2012 with no discrepancies.Supplier: (b)(4).As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer 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.
Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9, h3, h6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the exp 4.5 ti poly scw 5.00x35.Signs of normal use was observed.No significant product problem was observed on the surface of the device.The migration/backout/pull-out/subsidence issues could be not confirmed since x-ray evidence was not provided.A functional test could not be performed as the mating device was not returned.A dimensional inspection was not performed as it is not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the exp 4.5 ti poly scw 5.00x35 would not contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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.D4: lot.H4: a review of the receiving inspection (ri) for exp 4.5 ti poly scw 5.00x35 was conducted identifying that lot number rl240970 released in one batch.- batch1: lot qty of (b)(4) units were released jul 18, 2016 with no discrepancies.Supplier: (b)(4).As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.

• Brand Name: EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 4.5 X 5.0 X 35MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 17806979
• Report Number: 1526439-2023-01793
• Device Sequence Number: 17986851
• Product Code: MNI
• UDI-Device Identifier: 10705034105147
• UDI-Public: (01)10705034105147
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 186112535
• Device Lot Number: RL240970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 10/05/2023; 11/07/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/16/2023; 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXP 4.5 TI POLY SCW 5.00X35; EXP 4.5 TI SINGLE INNIE; EXP 4.5 TI SINGLE INNIE; EXP 4.5 TI SINGLE INNIE; EXP 4.5 TI SINGLE INNIE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown