MAUDE Adverse Event Report: SYNTHES GMBH VERTEBRAL BODY SET/SMALL- STERILE; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 09.804.600S

Device Problem Material Integrity Problem (2978)

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

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot: part # 09.804.600s, synthes lot # j001643, supplier lot # j001643, release to warehouse date: 09 oct 2020, expiration date: 01 sep 2023, supplier: confluent medical technologies.Nr-0150979 was generated due to the identified defect type: 0001426.The 383 pieces of this lot with all correct labelling will be released from hold.The single nonconforming piece will be returned to the supplier for disposal as is required by the import for export process.Device history review review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a surgery of percutaneous vertebroplasty due to th12 centrum fracture.The trial balloon was inflated in the centrum.When tried to retract the trial balloon through the sleeve, contrast medium leaked from the damaged trial balloon.It was unknown if the surgery completed successfully.The patient outcome was unknown.This complaint involves one (1) device.This report is for (1) unk - screws: distal femur.This report is 1 of 1 for (b)(4).

• Brand Name: VERTEBRAL BODY SET/SMALL- STERILE
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12297871
• MDR Text Key: 266929633
• Report Number: 8030965-2021-06539
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07611819471849
• UDI-Public: (01)07611819471849
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Catalogue Number: 09.804.600S
• Device Lot Number: J001643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1