MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 EXP VERSE UNITIZED SET SCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 186789480

Device Problem Migration (4003)

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

Event Type  Injury  

Manufacturer Narrative

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 9); 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) viper2 straight rod-480mm.This is report 2 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.Investigation summary: customer quality investigation: the implant(s) was not returned, and the investigation will be completed based on the supplied image(s).The image(s) was reviewed, and the complaint condition of migration was confirmed as the image(s) showed the rod was migrated from one of the screws resulting in the complaint condition.As the implant(s) was not returned and as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation was not performed as the lot number could not be determined from the image(s).There is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.

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.H3, h4, h6: the dhr of product code 199721001, lot wp2111, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on january 13, 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).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 # wp2111-- 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.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.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): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10587753
• MDR Text Key: 208747821
• Report Number: 1526439-2020-01806
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034133522
• UDI-Public: (01)10705034133522
• 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,Followup
• Report Date: 08/26/2020

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
• Device Operator: Health Professional
• Device Model Number: 186789480
• Device Catalogue Number: 199721001
• Device Lot Number: WP2111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 09/25/2020; 12/22/2020
• Supplement Dates FDA Received: 10/13/2020; 01/15/2021
• 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 EXP VERSE UNITIZED SET SCR; 5.5 MM TITANIUM ROD
• Patient Outcome(s): Required Intervention