MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	199723645
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
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.A2: patient's date of birth was reported as an unknown day in (b)(6) 1957.D1: brand name: expedium verse spine system fenestrated cortical fix polyaxial screw 5.5 6.0 x 45mm.D2b: additional device product codes: pml.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.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 synthes reports an event in the united kingdom as follows: it was reported that on (b)(6) 2022, the patient underwent surgery to implant the l45 interbody cage (concorde titanium oblique) at l45s1.No cage was placed at l5s1.A revision was performed on (b)(6) 2023 because one of the expedium verse advanced screws had broken.No specific event caused the fracture, but it seemed as the the patient had an associated bony fracture as well.The revision involved the replacement of the screw with a 7/50mm version, and all went fine.The patient is doing well after the case.During the surgery, one of the instruments stripped.Not much time was lost, as another was available to be used.The outcome was fine.This report involves one expedium verse spine system fenestrated cortical fix polyaxial screw 5.5 6.0 x 45mm.This is report 1 of 2 for (b)(4).
Event or Problem Description
The surgery was completed successfully without any delay.
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.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the photo revealed that the [5.5 exp verse fen scr 6.0x45] had broken at the middle section of the threaded part of the screw.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the [5.5 exp verse fen scr 6.0x45].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.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: FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 6.0 X 45MM
• 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: 16972955
• Report Number: 1526439-2023-00881
• Device Sequence Number: 2453528
• Product Code: MNI
• UDI-Device Identifier: 10705034403083
• UDI-Public: (01)10705034403083
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160879
• 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

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 Model Number: 199723645
• Device Catalogue Number: 199723645
• Device Lot Number: 248911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male