MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UNKNOWN

Model Number MSB_UNK_BKP_CEMENT

Device Problem Leak/Splash (1354)

Patient Problems Extravasation (1842); Pain (1994)

Event Date 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.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.Brand name, common device name , lot, product identifier is unknown, pma/510k: product identifier is unknown, hence 510k# is not available.Raphael lotan, oded hershkovich, yigal bronstein, and joel finkelstein ¿xx¿¿sacroplasty: a novel technique for management of ¿h-type¿ sacral insufficiency fractures.Doi.10.1177.21514593211049671.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: eight consecutive sif patients with immobility and pain investigated using ct and nuclear imaging confirmed ¿h"-type fracture.Demographics, pain level, and ambulation status were recorded.The long-term quality of life was evaluated using the odi questionnaire and pain vas scores.Sacroplasty procedures in prone positioning using fluoroscopy were used to insert 2 bone trocars through the s1 pedicles and 2 trocars through the sacral ale aiming toward the sij, thus forming 2 ¿x¿ trocar formations.Balloon kyphoplasty was done through the trocars, and pmm was injected.Postoperative ambulation and vas were recorded.Average age was 81.5 years (±3.4 years).A 10 mm inflatable balloon was introduced through the trocars (kyphon, medtronic) and inflated under fluoroscopic control.Then balloons were deflated and retracted.After mixing the pmma cement (hvr or xpede, medtronic), achieving toothpaste-like viscosity, under anteroposterior imaging, 2 to 5 ml of pmma was injected through each trocar, monitoring the spread of the bone cement to avoid medial extension toward the sacral nerve roots or anterior to the sacrum.Xx¿ technique showed good outcomes for patients with higher complexity sif, using the same principles as for lumbar vpl/kpl, and was found to be safe and effective.Results: the time from presenting symptoms to hospital admission was 2 days to 4 months.All patients were significantly limited with ambulation.None had a neurologic compromise.Sacroplasty was performed with 2 cases that required additional lumbar kyphoplasty.The mean operative time was 54 min (±14).The average exposure was 19 mgy (±12 mgy).Two patients had cement leaks.Ct and x-rays revealed good cement filling of the fractures sacral alae and body of s1.The average postoperative hospitalization was 10 days.All patients reported postoperatively pain relief immediately and were able to walk better.Follow-up time was 17 ± 12 months.Follow-up vas was 2.7 (±2) and odi was 57.3% (±21%).Reported events: two patients had cement leaks and underwent postoperative ct scans that revealed a leak to the sij joint in one case and sacral foramina in another, without neurologic compromise.One patient that developed gastrointestinal bleeding treated conservatively.One patient developed postoperative urinary retention, and a ct scan excluded cement leakage or neural compression.By discharge, the patient was weaned from the urinary catheter.During follow-up, 2 patients suffered a pertrochanteric hip fracture requiring operative treatment; a month and 2 months following the sif, another patient developed lumbar radiculopathy requiring selective nerve root blocks.The radiculopathy was unrelated to the lumbar kyphoplasty patients.

• Brand Name: UNKNOWN
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13962989
• MDR Text Key: 294885031
• Report Number: 1030489-2022-00304
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_BKP_CEMENT
• Device Catalogue Number: MSB_UNK_BKP_CEMENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2022
• 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