MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SINGLE-INNER SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 179702000

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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 Description

It was reported that on (b)(6) 2019, a posterior lumbar spinal fusion was performed with expedium ti 5.5 mm poly system from l2-l5, during a routine patient follow up it was noticed that the rods had come loose from the distal screws on the left side at l4 and l5 (locking caps came loose from the screws and were floating free).Only 1 rod came loose / out of the screw heads.The patient had mild back pain and did not know if this was due to the rod issue or not.The exact time of the patient office follow up visit is unknown must have been recent.On (b)(6) 2019, the surgeon performed the revision and removed both of the rods that had been cut into 2 segments.It was stated that the expedium set screws on the left side were loose and out of the screw heads at l5 and l4 (free-floating) and the l3 set screw was also loose at l3, but still attached to the screw head and holding the rod in.The left l2 set screw was tight.On the right rod, all the set screws were tight except l3.The surgeon then bilaterally replaced the expedium 7.5 mm x 60 mm poly screws at l4 and l5 with 8.0 x 60 mm screws.Thus, contoured new 120 mm cobalt chrome rods and connected the new rods with all the new set screws and successfully completed the procedure.The procedure was successfully completed.The patient outcome is good.Concomitant device reported: unknown set screws (part# unknown, lot# unknown, quantity unknown).This is report 07 of 09 of (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.H10 additional narrative: h3, h6: investigation summary.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the images provided.The image(s) were reviewed, and the complaint condition could be confirmed because the reviewed x-ray images indicate that several inner-set screws were loose and backed out slightly beyond the expedium ti poly screw tabs.Two set screws were completely disconnected from the expedium poly screws and floating freely as seen in the images.Since the device was not returned, dimensional inspection and a functional test were not able to be performed.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.A definitive assignable root cause could not be determined based on the provided information.During the investigation, no product design issues or discrepancies were observed (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.

• Brand Name: SINGLE-INNER SETSCREW
• 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: 9732595
• MDR Text Key: 192650200
• Report Number: 1526439-2020-00602
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034064307
• UDI-Public: (01)10705034064307
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• 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: 01/30/2020

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: 179702000
• Device Catalogue Number: 179702000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 03/26/2020
• Patient Sequence Number: 1
• Treatment: QUANTITY 4; QUANTITY 4; UNKNOWN LOCKING/SET SCREWS; VIPER2 STRAIGHT ROD480MM, COCR
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 142