MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Calcium Deposits/Calcification (1758); Loss of Range of Motion (2032); Discomfort (2330); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/rod construct accessories/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.

Event Description

This report is being filed after the review of the following journal article: bo q, et al (2017), lumbopelvic fixation of vertically unstable tile type c pelvic fractures combined with complex sacral fractures, china j trauma, volume 33, pages 510-515 (china) the objective of this study is to evaluate the clinical outcomes of lumbopelvic fixation of vertically unstable tile type c pelvic fractures combined with complex sacral fractures.Between may 2014 and december 2015, 21 patients with vertically unstable type c pelvic fractures combined with complex sacral fractures were included in the study.There were 10 males and 11 females with a mean age of 35.9 years (range, 14-59 years).These patients underwent lumbopelvic fixation using an unknown depuy spine 70mm or 80mm expedium spine system.All cases were followed-up for 12.5+/-5.4 months (range, 7-26 months).Complications were reported as follows: 1 male patient had mild to moderate pain in the lumbosacral region during walking, and the walking distance was limited to some extent, but he did not complain of pain at rest, and he did not need oral analgesics in daily life.2 patients had deep infections who were cured by debridement and antibiotics the internal fixation was not removed, and the infection was controlled.Internal fixation was removed one year after surgery and the fracture healed.2 patients had sacrococcygeal pressure ulcers ( 1 case of grade), 2 patients had heel pressure ulcers (length), and 1 patients had urinary tract infection, all of which were cured after treatment, without any skin pressure ulcers at the iliac screw.5 patients had screw loosening with no evidence of screw breakage.Radiographic reexamination 10~12 months after surgery showed no obvious discomfort.4 patients had foreign body sensation and discomfort in sacral area due to the prominence of the iliac hardware.1 patient was found to have a bursa formed in the tail of the iliac screw during the removal of internal fixation, which was removed simultaneously during the operation.4 patients range of motion was partially limited, mainly with flexion limitation.In 3 cases, the internal fixation was removed and the range of motion of the lumbar spine returned to normal.This report is for the unknown depuy spine 70mm or 80mm expedium spine system.A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 11821579
• MDR Text Key: 264467552
• Report Number: 1526439-2021-00950
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention