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

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

Patient Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

Product complaint #(b)(4).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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 korea, south as follows: this report is being filed after the review of the following journal article: kim s.K et al (2020) modified pedicle subtraction osteotomy for osteoporotic vertebral compression fractures, orthopedic surgery volume 12, number 2, pages 388¿395 (south korea) doi:10.1111/os.12589.This retrospective study aims to: (i) evaluate patients with ovcf with kyphotic deformity who underwent our modified pedicle subtraction osteotomy; (ii) analyze the clinical and radiological outcomes and complications of this osteotomy; and (iii) find out the usefulness of our spinal osteotomy for ovcf.Between november 2003 and july 2012, 20 patients (11 women, 9 men; mean age, 66 years [52¿79 years] diagnosed with ovcf and who underwent modified pedicle subtraction osteotomy were included in the study.Posterior fusion was performed from the two levels above to the two levels below using autologous bone grafts obtained from the body, lamina, and spinous process after osteotomy and instrumentation (moss-miami, depuy, warsaw, in, usa; monarch, depuy spine, inc., raynham, ma, usa).Mean follow-up, 39.6 months [24¿111 months].The following complications were reported: a case of a (b)(6)-year-old woman (patient no.2) with l1 osteoporotic compression fracture accompanying functional paraplegia showing a kyphotic angle of 23.5 degrees.A radiograph taken at 5 years postoperative shows increased kyphosis to 27.3 degrees (16.9-degree correction loss).However, the patient¿s pain relief and partial recovery of functional paraplegia were maintained.Ct scan taken at 5 years postoperative showing bone union of the osteotomy site and decompression of the spinal canal.A case of (b)(6)-year-old male (patient no.10) showing a kyphotic angle of 30.0 degrees.Postoperative shows increased kyphosis to 36.7 degrees.A case of a (b)(6)-year-old woman (patient no.20) with an l1 osteoporotic compression fracture showing a kyphotic angle of 52.1 degrees.The kyphosis progressed to 18.6 degrees at 2 years postoperative.(d) lateral plain radiograph taken at 4 years postoperative showing well maintained sagittal correction with kyphosis of 19.7 degrees.A 9.5-degree correction loss at the last follow-up through plain radiography.Ileus occurred immediately postoperatively in one case, but the patient recovered well with conservative treatment and early ambulation using the tlso brace.One case of cauda equina syndrome at 2 days post-operative.We performed emergency operation for hematoma removal and the motor grade recovered to fair.Two cases of proximal junctional kyphosis.Two cases of screw loosening, but in all cases the follow-up plain radiographs showed a solid fusion, and the screw loosening did not progress; therefore, revision surgery was not needed.This report is for an unknown depuy spine moss-miami and unknown depuy spine monarch.This report is for (1) unknown screw/rod construct accessories.This report is 6 of 8 for (b)(4).

• Brand Name: UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
• 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 ; SZ
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12098842
• MDR Text Key: 259357143
• Report Number: 1526439-2021-01358
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• 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: 06/09/2021
• 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