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

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the unknown cage was discovered as dislocated.No further information was provided.This report is for (1) unknown cage/spacer.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

This report is for an unknown cage/spacer/unknown lot.Part and lot numbers are unknown; udi number is unknown.Initial reporter is synthes sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.(b)(4).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: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 13693247
• MDR Text Key: 286764069
• Report Number: 1526439-2022-00355
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 03/08/2022
• 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: UNK - ROD VIPER; UNK - SET SCREW VIPER