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 Migration (4003)

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

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Additional device product code: kwp;kwq;mnh;mni;osh.(b)(4).This investigation is done based on the supplied image(s).The image(s) was reviewed and the complaint condition could not be confirmed as the image provided is not an x-ray but just a picture of the implant.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.A device history record (dhr) review was conducted: the dhr of product code: 199721001.Lot : wl1231.Was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 15.10.2019.Qty: 285.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.

Event Description

It was reported that on (b)(6) 2020, patient underwent t4-l3 pedicle screw fusion with expedium verse of unitized set screws & 300 mm cobalt chrome rods.The patient returned to clinic for postoperative visit complaining of pain in the lumbar spine area.Anterior/posterior (a/p) & lateral x-rays obtained which revealed that the rod was no longer locked in place on the right side at l3 & that the head of the right l3 screw was no longer locked in place.Based on these findings, the surgeon scheduled the patient to return to the operating room on (b)(6) 2020 for revision of the rod & unitized set screw.After exposure, the surgeon removed the implanted unitized set screw, which was still in the head of the screw but loose, placed the cobalt chrome rod back into the head of the right l3 screw, placed a new unitized set screw, compressed & performed final tightening to the right l3 unitized set screw.He further confirmed rod placement with an a/p x-ray & closed the incision.No further information provided.Concomitant device reported: screw (part# unknown, lot# unknown, quantity unknown); viper2 straight rod300mm, cocr (part # 196789300, lot # unknown, quantity 1).This report is for one (1) 5.5 exp verse unitized set scr.This is report 1 of 2 for (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d11: additional concomitant product h6: investigation summary: the implant(s) was not returned and instead the investigation will be done based on the supplied image(s) from the attachments (1 image(s) from the attachment(s) located in notes & attachments section of the product complaint).The image(s) was reviewed and the complaint condition could not be confirmed as the image provided is not an x-ray but just a picture of the implant.As the implant(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.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.Background: it was reported that on (b)(6) 2020, patient underwent t4-l3 pedicle screw fusion at shriners hospital in shreveport, la with expedium verse of unitized set screws & 300 mm cobalt chrome rods.The patient returned to clinic for postoperative visit with the surgeon at shriners hospital complaining of pain in the lumbar spine area.A/p & lateral x-rays obtained which revealed that the rod was no longer locked in place on the right side at l3 & that the head of the right l3 screw was no longer locked in place.Based on these findings, the surgeon scheduled the patient to return to the or at shriners on (b)(6) 2020 for revision of the rod & unitized set screw.After exposure, the surgeon removed the implanted unitized set screw, which was still in the head of the screw but loose, placed the cobalt chrome rod back into the head of the right l3 screw, placed a new unitized set screw, compressed & performed final tightening to the right l3 unitized set screw.He further confirmed rod placement with an a/p x-ray & closed the incision.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown) this complaint involves two (2) devices.Investigation flow: device interaction/functional visual inspection: the 5.5 exp verse unitized set scr (part #199721001/ lot #wl1231) was received at us cq.There were multiple visual defects observed with the returned set screw.The screw¿s threads were stripped and the distal face of the screw was deformed and scratched heavily, as the anodization has been scratched off.Although no x-rays were provided, the damaged condition of the threads and the set screw would not allow this device to properly lock so the overall complaint was confirmed.Functional test: functional testing was unable to be performed during investigation as the set screw was returned by itself.Due to the observed visual damage, the overall complaint was confirmed.Unable to perform functional test, but the complaint was confirmed.Dimensional inspection: specified dimensions: measured dimensions: device(s) used: om803 document/specification review: drawing(s) reviewed: (current & manufactured revisions) conclusion: the overall complaint was confirmed for the received 5.5 exp verse unitized set.Although no definitive root-cause can be determined its possible the device experienced unintended forces.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 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.

• 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: 10691284
• MDR Text Key: 211868972
• Report Number: 1526439-2020-01980
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• 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: WL1231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Date Manufacturer Received: 10/09/2020
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE UNITIZED SET SCR; UNKNOWN SCREWS; UNKNOWN SCREWS; VIPER2 STRAIGHT ROD300MM, COCR; VIPER2 STRAIGHT ROD300MM, COCR
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR
• Patient Weight: 50