MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 7.0X35; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 199723735S

Device Problem Device Slipped (1584)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Additional procode: kwp, kwq.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, a third revision surgery was performed due to screws being loose in the patient.The rod was reused, previous bbraun set screws were reused, and new set screws were placed.The cement was not intact.Part was left insitu - other part around screw.The procedure was successfully completed.The patient was osteopaenic/osteoporotic.The original surgery was performed in 2012.The second revision surgery was performed in 2018.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity unknown).Bbraun setscrews (part# unknown, lot# unknown, quantity unknown).This report is for one (1) 5.5 exp verse fen scr 7.0x35.This is report 1 of 6 for (b)(4).

Event Description

It was reported that on (b)(6)2020 that the patient underwent a revision operation due to loosened s1 screws.The original surgery was done in 2012 and a revision was completed in 2018 with a l4/s1 fusion using expedium cfx 9x50 screws in l4 with cement augment, l5 had 6x50 screws (insitu) and s1 7x35 verse screws with cement augmentation.The loosened screws were able to be removed without a screw driver.The defect was filled and cfx 10x40(right) and 10x45(left) where inserted.The rod was reused, new set screws were implanted at l4& s1 and the set screws were reused at l5.The cement was not intact and the part was left insitu with the other part around the screw.The patient was osteopaenic/osteoporotic but the procedure was successfully completed.

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.H6: customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the images and videos provided.The image(s) and the videos were reviewed, and the complaint condition could not be confirmed, the images and the videos do not show any sign of loose screws.Since the device was not returned, a 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: 5.5 EXP VERSE FEN SCR 7.0X35
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10979370
• MDR Text Key: 220671053
• Report Number: 1526439-2020-02374
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034444529
• UDI-Public: (01)10705034444529
• Combination Product (y/n): N
• PMA/PMN Number: K173095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199723735S
• Device Catalogue Number: 199723735S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2021
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE FEN SCR 7.0X35; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR