MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number	179762480
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
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: d9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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 synthes reports an event in japan as follows: it was reported that the patient reported in (b)(4) is scheduled to undergo revision surgery again.The patient underwent the 1st revision surgery via spinal fusion on (b)(4) 2022, and it was completed successfully with no surgical delay.After the 1st revision surgery, breakage of the rods occurred.The second revision surgery was performed on (b)(6) 2023, as scheduled.Regarding the right side, the rods were broken off at a cranial side of t10, and regarding the left side, the rods were broken off at a cranial side of t11.The broken rods, expedium cfs screws, sfx cross connectors, rod connectors, and top-notch universal connectors, etc.Were removed, and a fixation (t1-l2) was done.The second revision surgery was completed successfully.The surgeon commented that the cause of the breakage of the rods this time was due to non-union, and that the event was no product related.No further information is available.This report is for one (1) unknown rods this is report 5 of 5 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d1: brand name updated.D2a: procode, common device name updated.D4: catalog number, udi added.D9: device returned.G1: manufacture site added.G4: 510k added.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.H3, h4, h6: photo investigation: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that rod, 480 mm had broken.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for rod, 480 mm.There is no indication that a design or manufacturing issue has caused the complaint condition.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 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.D10: concomitant devices updated.Date of concomitant therapy is (b)(6) 2022.
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: 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 device found that the rod, 480 mm was broken from at one end.Of signs of malformed were also observed.The broken fragment was not returned for evaluation.No other issues were observed.A dimensional inspection for the rod, 480 mm was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the rod, 480 mm would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 17798610
• Report Number: 1526439-2023-01786
• Device Sequence Number: 12523002
• Product Code: NKB
• UDI-Device Identifier: 10705034077437
• UDI-Public: (01)10705034077437
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• 2 Devices were Involved in the Event: 1 2

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: 179762480
• 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: 09/03/2023
• Supplement Date Received by Manufacturer: 09/25/2023; 11/03/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 10/25/2023; 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: CONN O/O SD TOP NTCH 5.5X5.5 T; CONN O/O SD TOP NTCH 5.5X5.5 T; CONN O/O SD TOP NTCH 5.5X5.5 T; CONN O/O SD TOP NTCH 5.5X5.5 T; ROD, 480 MM; ROD, 480 MM; ROD, 480 MM; ROD, 480 MM; ROD, 480 MM; ROD, 480 MM; ROD, 480 MM; UNK - SCREWS: EXPEDIUM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female