MAUDE Adverse Event Report: DEPUY SPINE INC UNKNOWN CAGE/SPACER; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Catalog Number UNK CAGE/SPACER

Device Problem Migration (4003)

Patient Problem Non-union Bone Fracture (2369)

Event Date 12/05/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that this was an intervertebral plif for the stenosis on (b)(6) 2021.After the surgery, the screw loosened, and the cage backed out to the spinal canal.In january, a revision surgery will be performed.The surgeon wondered why the cage backed out and thought that the implants were not good.Possible causes other than device is the screw loosened and the cage backed out due to loosening because of the lack of bone union.As of (b)(6) 2022 the opco concerned and the product details are not available.No further information is available.This report is for one (1) unknown cage/spacer.This is report 1 of 2 for complaint (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown cage/spacer/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter name and address:(b)(6) japan.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

His is report 1 of 1 for complaint (b)(4).

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.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.

• Brand Name: UNKNOWN CAGE/SPACER
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16077639
• MDR Text Key: 306422643
• Report Number: 1526439-2022-02228
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CAGE/SPACER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• 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 CAGE/SPACER.; UNKNOWN SCREWS.
• Patient Outcome(s): Required Intervention