MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON FENESTRATED SCREW SET; DISPENSER, CEMENT

Model Number 6550202

Device Problem Mechanics Altered (2984)

Patient Problems Abrasion (1689); Extravasation (1842)

Event Date 05/15/2021

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional via manufacturer representative regarding a patient having unknown indication for spinal therapy.It was reported that during the surgery, there were difficulties in assembling/twisting the cement sleeve into the tulip and subsequently there was cement leakage.For the patient, it was reported that there was long operation time, procedure change to open technique, screws were not cemented in the end and remaining cement, metal abrasion.There was cement leak inside the patient.There was 120 mins procedural delay.

• Brand Name: CD HORIZON FENESTRATED SCREW SET
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 12007251
• MDR Text Key: 256455712
• Report Number: 1030489-2021-00798
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 00763000211035
• UDI-Public: 00763000211035
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6550202
• Device Catalogue Number: 6550202
• Device Lot Number: KH19K514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2021
• Date Device Manufactured: 05/12/2020
• 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
• Patient Age: 82 YR