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

Device Problem Mechanical Problem (1384)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Event Description

Device report from synthes reports an event in china as follows: this report is being filed after the review of the following journal article: tian d., et al (2021) a modified triangular osteosynthesis protocol for the rod and pedicle screw fixation of vertical unstable sacral fractures, international journal of spine surgery, vol.15, no.3, pp.485¿493 (china).This study aims to investigate the clinical outcomes by radiology and examined the reduction and fixation of vertical unstable sacral fractures.From october 2010 to july 2016, 28 patients with vertical unstable sacral fractures were recruited (male, 16; female, 12; median age of 30 [16¿59] years.A vertical and transverse fixation with a universal spinal system (uss) rod and pedicle screw system (uss fixateur interne; synthes usa) during the procedure were adopted to reduce and fix sacral fractures in 28 subjects.First, pedicle screw insertion points were identified.After tapping, 2 pedicle screws were inserted into the pedicle of l4 and l5.Another 3 pedicle screws were inserted into the ilium between the inner and outer cortices as an iliac screw.Then a straight rod was precurved into an l shape with the angle according to screws position in l4, l5 pedicle, and iliac bone through the psis that consisted of a vertical fixation; the rod was connected with the iliac bone through the psis to finalize a vertical fixation.All 28 subjects were followed up for an average of 20 (16¿32) months with routine visits occurring at 1, 3, 6, 12, 24, and 32 months for physical and radiographic examinations.Reported complications: - superficial infection was reported in 4 cases, and this was treated with surgical debridement and local antibiotics.The wound was recovered in 4 weeks; so was the fracture union in 5 months.- two patients had complaints related to distal screws inserted in the region of the posterior-superioriliac- spine (psis); the tenderness disappeared after implant removal within 10 months.- two patients reported mild pain on gait that was located at the low back region; however, they did not need pain medication.- after a follow up of 20 months, radiological evaluation showed that fracture fragment reduction was fair (displacement 10¿15 mm) in 2 patients.Vertical reduction was fair in 3 of the cases.-figure 2.(a)¿(c) radiographs of a 16-year-old girl with right vertical unstable sacral fractures and right femur fractures, showing a preoperation anteroposterior xray, computed tomography (ct) coronal and 3-dimensional view and (d) the immediate postoperative scans after reduction and internal fixation.(e).Postoperative anteroposterior x-ray at the second month.(f) loosening of the hardware was detected at the fifth month.(g)¿(h) a follow-up view at the 10th month.(i) the anteroposterior x-ray at the 11th month indicates hardware removal; no loss of reduction was detected.A copy of the literature article is being submitted with this medwatch.This report involves one unk - mono/polyaxial screws: uss.This is report 4 of 4 for (b)(4).

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.Additional narrative: 510k: this report is for an unknown mono/polyaxial screws: uss.Device available for evaluation: 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, PEDICLE SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16071014
• MDR Text Key: 306365722
• Report Number: 8030965-2022-11665
• Device Sequence Number: 1
• Product Code: MNI
• 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,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• 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: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK - RODS: USS
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR
• Patient Sex: Female