MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS LUMBAR DECOMPRESSION (ISLD70)

Model Number ISLD70G

Device Problem Component Incompatible (1108)

Patient Problem Local Reaction (2035)

Event Date 06/06/2022

Event Type  Injury  

Event Description

Patient 3 of 3.(b)(6) hospital reported patient surgical infection(s).The hospital has not identified the reported lumbar decompression kit is the source; however, it is one of the devices which was utilized during procedure(s).Additional information was received on 01aug2022 that states, there was a total of three packs used during surgery with the same lot number (843221).This occurred with three different patients that developed infections.

Manufacturer Narrative

The product involved in the event has not been received but a sample is anticipated from the reporter for evaluation.Patient 3 of 3.(b)(6) hospital reported patient surgical infection(s).The hospital has not identified the reported lumbar decompression kit is the source; however, it is one of the devices which was utilized during procedure(s).Additional information was received on 01aug2022 that states, there was a total of three packs used during surgery with the same lot number (843221).This occurred with three different patients that developed infections.All information reasonably known as of 08aug2022 has been included in this medical device report.The information provided by o&m halyard, inc.Represents all of the known information at this time.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.

Manufacturer Narrative

The product involved in the event was not returned for evaluation."after a thorough investigation with the team, including process, system, records, and evaluation, no immediate cause could be identified, that would have caused or contributed to the reported incident.It is noteworthy that the complainant identified an infection; therefore, as part of the investigation, would include a request for the tray supplier to conduct an internal investigation." all information reasonably known as of 28sep2022 has been included in this medical device report.The information provided by o&m halyard, inc.Represents all of the known information at this time.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to (b)(6), in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.

• Brand Name: LUMBAR DECOMPRESSION (ISLD70)
• Type of Device: LUMBAR DECOMPRESSION (ISLD70)
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS; 1601 se gateway drive; suite 120; grimes IA 50111
• Manufacturer (Section G): AMERICAN CONTRACT SYSTEMS; 1601 se gateway drive; suite 120; grimes IA 50111
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 15183621
• MDR Text Key: 297434581
• Report Number: 3007069947-2022-00003
• Device Sequence Number: 1
• Product Code: OJG
• UDI-Device Identifier: 09501101020016
• UDI-Public: 9501101020016
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ISLD70G
• Device Catalogue Number: ISLD70G
• Device Lot Number: 843221
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other