MAUDE Adverse Event Report: SYNTHES GMBH UNK - RETRACTOR: SYNFRAME

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

Patient Problem Wound Dehiscence (1154)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: singh, s., et al.(2022), minimally invasive deformity correction technique: initial case series of anterior lumbar interbody fusion at l5-s1 for multilevel lumbar interbody fusion in a lateral decubitus position, world neurosurgery, vol.162 (xx) pages e416-e426.(usa).The aim of this retrospective study was to report the acute surgical outcomes following ld-alif and ld-llif and their ability to achieve restoration of spinopelvic alignment without requiring posterior column osteotomies or direct posterior decompression.Between september 2020 and december 2021, a total of 12 consecutive patients (4 males and 8 females) who underwent l5-s1 alif in the lateral decubitus position and anterior-to-psoas llif at more cranial levels as part of a multilevel lumbar interbody fusion surgery without major complications and reported improvement of their preoperative symptoms at follow-up appointments.All patients exhausted conservative therapy options including 6 weeks of formalized physical therapy and trials of epidural injections.The synframe access and retractor system was used to better visualize and safely identify the lumbar spine region (synframe, depuy synthes, raynham, pa).The interbody cage (conduit, depuy synthes, raynham, pa) was then used inside the disc space.A competitor device was used for abdominal fascial layers.The median follow-up was unknown.The following complications were reported as follows: - 1 patient with a wound dehiscence in her posterior paramedian incision used for the placement of percutaneous screws and rods requiring a return to the or for wound revision.- 1 patient with grade i subsidence of the graft at l4-l5.This report is for unknown retractor blade (synframe, depuy synthes).A copy of the literature article is being submitted with this medwatch.This is report 1 of 1 for pc-001342009.This complaint is related to complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: 510k: this report is for an unknown synframe retractor blade/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 - RETRACTOR: SYNFRAME
• Type of Device: RETRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 16892040
• MDR Text Key: 314800642
• Report Number: 8030965-2023-05921
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• 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: 04/24/2023
• 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