MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG UNKNOWN; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number MSB_UNK_SET SCREW

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 09/02/2022

Event Type  Injury  

Manufacturer Narrative

A2: the average age of both patients was 63 years.This value is the average age of the patients reported in the article as specific patients could not be identified.A3a: the most common gender was male.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.B3.Please note that this date is based off of the date of publication of article as the event dates were not provided in the published article.D4: product identifier is unknown.G4: 510(k) is unknown.Citation: christopher t.Martin, md, kenneth j.Holton, md, benjamin d.Elder, md, phd, jeremy l.Fogelson, md, anthony l.Mikula, md, christopher j.Kleck, md, david calabrese, ms, evalina l.Burger, md, david w.Polly jr., md.Catastrophic acute failure of pelvic fixation in adult spinal deformity requiring revision surgery: a multicenter review of incidence, failure mechanisms, and risk factors.J neurosurg spine 38:98¿106, 2023.Doi: 10.3171/2022.6.Spine211559.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Summary: thirteen academic medical centers performed a retrospective review of 18 months of consecutive adult spinal fusions extending 3 or more levels, which included new pelvic screws at the time of surgery.Acute pelvic fixation failure was defined as occurring within 6 months of the index surgery and requiring surgical revision.Demographics and surgical characteristics were collected including age, gender, bmi, osteotomies performed, levels and number of osteotomies, screw implant manufacturer, pelvic screw trajectory 9iliac or s2ai), size and diameter of the pelvic screws, number of pelvic screws placed, and the number of spinal levels instrumented.Reported revision strategies in 37 of the cases consisted of posterior revision surgery and involved placing new pelvic instrumentation with or without multi-rod constructs spanning to the pelvis.One patient underwent revision using l4¿s1 anterior interbody fusion in addition to posterior to revision instrumentation.Six (16%) of the 37 patients then sustained a second acute failure of their pelvic instrumentation that required a second revision surgery within 6 months.All 6 of these patients underwent initial revision with posterior fixation consisting of less than 4 rods to the pelvis.No secondary failures occurred in the cases with 4-rod constructs terminating in at least 4 pelvic fixation points.Results: 1.Failure occurred in 37 (5%) of 779 cases and consisted of either slippage of the rods or displacement of the set screws from the tulip head, screw shaft fracture, screw loosening, and/or resultant fracture of the sacrum.2.Set cap dislodgement from the pelvic fixation was the most common failure mechanism, occurring in 17 (46%) of 37 failure cases.3.The mean time from the index surgery to the failure diagnosis was 62+/-51.7 days.All of these patients underwent a surgical revision of the pelvic instrumentation.4.Screw loosening occurred in 9 patients.5.Pelvic screws were broken in 9 patients.6.Rods broken across lumbosacral junction in 6 patients.7.6 patients had sacral or iliac fracture.See attached literature.

• Brand Name: UNKNOWN
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 18736497
• MDR Text Key: 335730232
• Report Number: 1030489-2024-00116
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SET SCREW
• Device Catalogue Number: MSB_UNK_SET SCREW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male