MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE UNITIZED SET SCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 199721001

Device Problem Device Slipped (1584)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional device product codes: kwp;kwq;mnh;mni;osh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).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 Description

It was reported that a patient underwent revision on (b)(6) 2020 due to the spinal rod had migrated superiorly.During the revision the unitized set screws and rods were replaced.The patient had previously implanted verse pedicle screws, verse unitized set screws, and 5.5 mm titanium rods.All the 4 sets screws on the left hand side were loose which allowed the left rod to migrate and during the surgery the 5 set screws on the right were identified to be loose also.The right rod did not move.The surgeon replaced all 9 set screws and 2 rods.The surgeon performed a revision by replacing the unitized set screws and rods.Concomitant devices reported: 5.5 exp verse unitized set scr (part # 199721001, lot # unknown, quantity 8); viper2 straight rod-480mm (part # 186789480, lot # unknown, quantity 1); 5.5 expedium verse screws (part# 1997-21-645, lot# unknown, quantity unknown); 5.5 mm titanium rod (part# unknown, lot# unknown, quantity 1).This report is for one (1) 5.5 exp verse unitized set scr.This is report 7 of 10 for (b)(4).

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 dhr of product code 199721001, lot xc2113, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on february 10, 2020.Qty.(b)(4).The dhr was electronically reviewed.Nine 5.5 exp verse unitized set scr were returned to depuy synthes for evaluation.Visual inspection and dimensional inspections were performed at us customer quality (cq).The associated photos/x-rays were investigated under this investigation.No functional testing could be performed as the set-screws were returned without relevant mating devices.The received physical devices showed no damage outside of wear.The wear marks were likely caused by forces exerted during implantation/explanation of the device.Based on the returned photos/x-rays, it can be determined that at a minimum, four of the nine set screws were loose.Since it is not possible to determine which set screw belongs to the left side construct, the complaint condition will be confirmed for each part/lot combination of set-screw.Since the relevant screws were not returned, it was not possible to test the functionality of the set-screws.Dimensional inspection found no non-conformances.All relevant measurements were measured and found conforming.A manufacturing record evaluation was performed for the finished device --product code # 199721001 lot # xc2113-- and no non-conformances were identified.It should be noted that as part of depuy synthes¿s quality process all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.Although no conclusion could be reached on the cause of the reported event its possible the set-screw was subjected to unexpected forces.No functionality impairing damage could be identified with the returned devices, but since the photos x-rays clearly shows a defect, the complaint condition was confirmed.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.Dimensional inspection: measured dimensions: major diameter = conforming.Height = conforming.Document/specification review: drawing(s) reviewed: (current & manufactured revisions).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 UNITIZED SET SCR
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10587875
• MDR Text Key: 208583347
• Report Number: 1526439-2020-01811
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466156
• UDI-Public: (01)10705034466156
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199721001
• Device Catalogue Number: 199721001
• Device Lot Number: XC2113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Date Manufacturer Received: 12/22/2020
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE SCREW 6.0 X 45; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 MM TITANIUM ROD; VIPER2 STRAIGHT ROD-480MM; 5.5 EXP VERSE SCREW 6.0 X 45; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 MM TITANIUM ROD; VIPER2 STRAIGHT ROD-480MM
• Patient Outcome(s): Required Intervention