MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM VERSE SPINE SYS FENESTRATED CORTICAL FIX POLY SCREW 5.5 5.0 X 50MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	199723550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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 (b)(6) reports an event as follows: it was reported that on an unknown date, revision surgery was performed for removal of a broken screw used in a stabilization primary surgery on (b)(6) 2019.A new screw was replaced.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity 1).Unknown setscrews part# unknown, lot# unknown, quantity unknown).This complaint will capture the post-op event (revision surgery due to removal of a broken screw) while (b)(4) will capture the intra-op event (it was not possible to extract the fragment during revision surgery).This report is for a expedium verse spine system fenestrated cortical fix polyaxial screw 5.5 5.0 x 50mm.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.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
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.H10 additional narrative: d10: device returned.H3, h4, h6: a review of the device history record has.Device history lot.Part number: 199723550.Lot number: 236662.A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure (b)(4) no manufacturing record evaluation is required.H3, h6: investigation summary background: revision surgery due to the removal of a broken screw used in a stabilization primary surgery of (b)(6) 2019.A new screw was placed.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity 1) unknown setscrews part# unknown, lot# unknown, quantity unknown) this complaint involves one (1) device.Investigation flow: damage.Visual inspection: the 5.5 exp verse fen scr 5.0x50 (p/n: 199723550, lot #: 236662) was returned and received at us cq.Upon visual inspection, it was observed that the distal tip of the device was broken.There were scratches on the device consistent with explanation and have no impact on the functionality of the device.No other issues were identified with the returned device.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed.Expedium verse 5.5 system: 887046745, rev.B.Expedium verse 5 x45-80 fenestrated of shank: 887046626, rev.A.The device received was broken.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the 5.5 exp verse fen scr 5.0x50 (p/n: 199723550, lot #:236662).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential root cause could be due to unintended forces applied to the device.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.
Additional 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.H10 additional narrative: d4: exp date.H11: re-opened complaint for dhr information to be added.H3, h4, h6: a review of the device history record.Device history lot.A review of the device history record (dhr).Part # 199723550s.Lot # 236662.Release to warehouse date: 22 mar 2018.Expiration date: 29 feb 2024.A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure (b)(4).No manufacturing record evaluation is required.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: EXPEDIUM VERSE SPINE SYS FENESTRATED CORTICAL FIX POLY SCREW 5.5 5.0 X 50MM
• 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: 9701901
• Report Number: 1526439-2020-00527
• Device Sequence Number: 2824847
• Product Code: MNI
• UDI-Device Identifier: 10705034403243
• UDI-Public: (01)10705034403243
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/21/2020

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 Expiration Date: 02/29/2024
• Device Model Number: 199723550
• Device Catalogue Number: 199723550
• Device Lot Number: 236662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 02/13/2020; 03/13/2020; 03/17/2020; 04/24/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 02/14/2020; 03/16/2020; 04/10/2020; 04/28/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR