MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 6.0X45; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	199723645
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Spinal Column Injury (2081); No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event occurred on an unknown date in 2018.Additional procode: mni.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).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 (b)(6) as follows: it was reported that the verse advanced screws broke in the vertebral body post-operation.There is no further information available.Concomitant device reported: verse correction key (part# 199721000 , lot# 206919, quantity 1); verse correction key (part# 199721000 , lot# 196158, quantity 1); verse correction key (part# 199721000 , lot# 190651, quantity 1); verse correction key (part# 199721000 , lot# 190159, quantity 1); 5.5 exp verse fen scr 6.0x45 (part# 199723645, lot# 155845, quantity 1); 5.5 exp verse fen scr 6.0x45 (part# 199723645, lot# 184191, quantity 1); 5.5 exp verse fen scr 6.0x45 (part# 199723645, lot# 175103, quantity 1); 5.5 exp verse fen scr 6.0x45 (part# 199723645, lot# 184192, quantity 1).This report is for one (1) 5.5 exp verse fen scr 6.0x45.This is report 1 of 8 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.H11: correct data: g4: awareness date reported on initial report as december 03, 2018 but should have been september 22, 2020.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.Investigation summary: visual inspection: the 5.5 exp verse fen scr 6.0x45 (part #: 199723645, lot #: 184192) was received at us customer quality (cq).The visual inspection performed on the returned device did not reveal any damage.Device failure/defect identified? no.Dimensional inspection: drawing: dwg-887046645 rev a.Major diameter of the screw shank: conform.Device used: hand micrometer om521.Document/specification review: the following drawings were reviewed.Dwg-887046745 rev b and rev a (current and manufactured to) - expedium verse 5.5 fenestrated screw assembly.Dwg-887046645 rev a (current and manufactured to) - expedium verse 6 x 45-80 fenestrated cf shank.Dwg-887042534 rev a (current and manufactured to) - expedium verse cap.Dwg-887042536 rev a (current and manufactured to) - expedium verse drag ring.Dwg-887042533 rev a (current and manufactured to) - expedium verse drag screw head.No design issues or discrepancies were identified.Complaint confirmed? no.Investigation conclusion: this complaint is not confirmed as the complaint device 5.5 exp verse fen scr 6.0x45 (part #: 199723645, lot #: 184192) was inspected and there was no issue reported.No definitive root cause could be determined based on the information provided.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.The dhr of product code: 199723645.Lot : 184192 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: feb 21, 2018.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 FEN SCR 6.0X45
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10580940
• Report Number: 1526439-2020-01778
• Device Sequence Number: 2836213
• Product Code: PML
• UDI-Device Identifier: 10705034403083
• UDI-Public: (01)10705034403083
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2018

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: 184192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 09/24/2020; 09/22/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 09/24/2020; 10/07/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.5 EXP VERSE FEN SCR 6.0X45; 5.5 EXP VERSE FEN SCR 6.0X45; 5.5 EXP VERSE FEN SCR 6.0X45; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; 5.5 EXP VERSE FEN SCR 6.0X45; 5.5 EXP VERSE FEN SCR 6.0X45; 5.5 EXP VERSE FEN SCR 6.0X45; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY
• Outcome Attributed to Adverse Event: Required Intervention