MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREWS; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: 510k: this report is for an unk - screws/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 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.The product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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 turkey as follows: this report is being filed after the review of the following journal article: user m., (2021) minimally invasive approach toward percutaneous direct pars repair: an observational study, world neurosurg.Volume 146, pages e1301-e1306 (turkey) https://doi.Org/10.1016/j.Wneu.2020.11.165.This prospective study aims to analyze the clinical, functional, and radiologic outcomes of pars defects repaired percutaneously via a minimally invasive technique.A total of 18 patients, including 10 men and 8 women with mean age 23.7 _ 4.26 years (range, 18e32 years) patients with lumbar spondylosis who did not respond to conservative treatment underwent surgery performed by the same surgeon via a minimally invasive approach.During surgery a cannula transfacet screw (perpos; depuy synthes, warsaw, indiana, usa)was used.The transfacet screws were 30-50 mm long and included a titanium cannula 4.0mmin diameter.The average follow-up time was 16.04 months (range, 12e28 months).The following complications were reported: in the remaining 4 patients who did not experience pain, no radiologic fusion was observed.Revision surgery was performed in 1 patient owing to the development of postoperative root irritation.This patient did not have any pain symptoms at the 3-month and 1-year follow-up examinations.1 patients had grade 1 spondylolisthesis according to the meyerding classification.The clinical and radiologic recovery of patients with spondylolisthesis took a relatively long time.The mean pelvic incidence increased to 56.17-5.18, while the mean lumbar lordosis increased to 64.78-4.25.An athlete with grade 1 spondylolisthesis reported a reduction in preoperative pain, although she experienced similar occasional occurrences of low back pain.The patient used analgesics regularly for this reason.The clinical outcome of this patient was rated to be moderate.The clinical and radiologic recovery of patients with spondylolisthesis took a relatively long time.This report is for an unknown depuy spine cannula transfacet screw (perpos).A copy of the literature article is being submitted with this medwatch.This report is for one (1) unknown screws.This is report 2 of 2 for complaint (b)(4).

• Brand Name: UNKNOWN SCREWS
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS 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 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12666095
• MDR Text Key: 277445017
• Report Number: 1526439-2021-02224
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• 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