MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN KITS/SETS; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

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

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 10/08/2019

Event Type  Injury  

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.D1, d2, d3, d4, g4 - 510k: this report is for an unknown kit/set/unknown lot.Part and lot number are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is synthes legal counsel.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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.

Event Description

It was reported that patient underwent revision surgery on (b)(6) 2019, due to pain and broken hardware.Patient originally underwent a posterior spinal decompression (laminectomy) on (b)(6) 2019.The patient was treated with the insertion of a bone graft kit and related parts, including hardware and screws.On (b)(6) 2019 the sutures were removed from the second surgery.The patient continued to have extreme pain and discomfort and returned to surgeon because of surgical site discharge and the incision opening.On (b)(6) 2019 the patient underwent debridement, with continued drainage, blood, and pain in the incision site.This report is for an unknown kit/set.This is report 3 of 3 for (b)(4).

• Brand Name: UNKNOWN KITS/SETS
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 16895129
• MDR Text Key: 314824533
• Report Number: 1526439-2023-00811
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2023
• 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
• Treatment: UNKNOWN PLATES.; UNKNOWN SCREWS.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female