MAUDE Adverse Event Report: SYNTHES GMBH UNK - MONO/POLYAXIAL SCREWS: USS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problem Patient Device Interaction Problem (4001)

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

Event Type  malfunction  

Event Description

This report is being filed after the review of the following journal article: beck, m.Et al (2012), reliability and consequences of intraoperative 3d imaging to control positions of thoracic pedicle screws, archives of orthopaedic and trauma surgery, vol 132 (xx), pages 1371¿1377 (germany).The aim of this prospective study is to clarify whether an intraoperative 3d scan is a reliable method for determining the position of thoracic pedicle screws.Between october 2008 to december 2010, a total of 40 patients (27 male and 13 female) with an average age of 45.8 years (range 11-78 years) were included in the study.Surgery was performed using "universal spine system" (uss, synthes, umkirch near freiburg, germany) with pedicle screws 4.0¿6.0 mm in diameter.The mean follow-up period was unknown.The following complications were reported as follows: 9 screws in 8 patients were assessed as relevant misplacements seen in 3d scans intraoperatively, and these were immediately repositioned (5 lateral, 4 medial misplacements).Five of the corrected ps were checked in a repeat 3d scan (fig.3a, b).34 pedicle screws were moderately malpositioned (type ib 10x, type iia 10x, type iib 14x) seen in the ct scan evaluations.When the ct and 3d scans were compared, it was found that 9 out of 10 ps had been correctly recognized by 3d scans as type ib, 8 out of 9 ps as type iia and 13 out of 14 ps as type iib.5 ps were incorrectly classified by one classification level; there were no incorrect classifications by two classification levels.41 screws were found to be penetrated the cortical bone to a minimal extent in the postoperative computed tomography.84 screws perforated the pedicles up to a width of 2 mm in the postoperative computed tomography.4 screws extended beyond the pedicle wall up to 3 mm in the postoperative computed tomography.This report is for an unknown synthes uss mono/polyaxial screws.This report is for one (1) unknown mono/polyaxial screws: uss.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown mono/polyaxial screws: uss/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between october 2008 to december 2010.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.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.

• Brand Name: UNK - MONO/POLYAXIAL SCREWS: USS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11739884
• MDR Text Key: 280680903
• Report Number: 8030965-2021-03387
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2021
• Removal/Correction Number: N/A
• Patient Sequence Number: 1