MAUDE Adverse Event Report: SYNTHES GMBH UNK - RODS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problem Material Integrity Problem (2978)

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

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - rods/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 (b)(6) as follows: this report is being filed after the review of the following journal article: hoffmann m.F., yilmaz e., norvel d.C., schildhauer t.A., (2021) navigated iliac screw placement may reduce radiation and or time in lumbopelvic fixation of unstable complex sacral fractures, european journal of orthopedic surgery & traumatology volume xxxx, pages 1-7(germany).This study aims to determine if navigated iliac screw placement for lumbopelvic fixation influences surgical time, fluoroscopy time, radiation exposure, accuracy of screw placement, and complication rates.From july 2011 through april 2018, 77 patients that had a lumbopelvic fixation for pelvic fractures or instabilities were identified.(63) patients (27 males, 36 females) with a mean age of 58 years (range 18¿87) were included in the study.32 patients underwent bilateral lumbopelvic fixation utilizing conventional fluoroscopic imaging alone (standard group) and 31 patients underwent the procedure with 3d navigated iliac screw placement (navigation group).Lumbopelvic implants (uss ii, depuy synthes, paoli, pa) were used.Screw size used was based upon length from the recessed entrance of the psis, along the sciatic buttress, and ending at the anterior inferior iliac spine (aiis) and was 7.0 or 8.0 mm × 110¿130 mm (uss ii, titanium, depuy synthes, paoli, pa).Screw length averaged 111.6 ± 7.7 mm was used in the standard group and 108.4 ± 8.2 mm in the navigated group.The following complications were reported: additional surgeries were required in twenty-six patients.17 patients in the standard group and nine patients in the navigated group.The reason for revision surgery was irrigation and debridement for hematoma or infection in 15 cases.Other reasons for revision surgeries were additional bone grafting for delayed spondylodesis (4), disconnected drainage (1), extended decompression for persistent neurologic symptoms (1).One patient returned for hardware removal 1 year after the initial surgery.3 non-union in patients who required hardware exchange due to broken rods.Soft tissue-related complications three patients required hardware exchange for broken rods in nonunion formation.One of the 63 patients had a malpositioned pedicle screw that needed revision.The malpositioned screw happened to be in the standard group.This report is for an unknown synthes lumbopelvic implants (uss ii), and unknown 7.0 or 8.0 mm × 110¿130 mm (uss ii) screw.This report is for (1) unk, rods.This report is 4 of 5 (b)(4).

• Brand Name: UNK - RODS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11872046
• MDR Text Key: 266082619
• Report Number: 8030965-2021-04210
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2021
• 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