MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH TI CONC BULLET LORD 9X9X27; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	196927519
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The following was reported: date j&j became aware: (b)(4) 2019.Date of event: (b)(6) 2019.Name of reporter: (b)(6).Hospital name: (b)(6) hospital.Surgeon: mr (b)(6).Hospital town: (b)(6).Product name: concorde titanium cage (9x9x27mm, lordotic).Product code: 196927519.Lot/batch/exp: 511996.Did the event happen during a procedure? no.Were you in the procedure at the time of the event? no.Was the product being used in a clinical trial? no.Event outcome/how was it managed? the cage was removed and a new larger cage inserted (196927511).Was there a patient impact or was the procedure extended greater than 30 minutes due to the failure? no.Has the reporter facility indicated there may be legal action? no.Is the product available for return? provided its returned from cssd.Please give a detailed explanation of the event: mr (b)(6) had performed a previous l4/5 tlif with concorde ti and expedium verse.A few months post op the patient returned to the hospital after sensing a popping sensation in their back on activity.X rays showed that the implant had begun to back out- the reason for the revision surgery.Mr (b)(6) revised the cage inserting another titanium concorde size 11mm following disc clearance and trialing.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Udi: (b)(4).The device features signs of use such as surface marking.However, the concorde bullet featured no signs of migrating or backing out.No other damage was noted.No postoperative x-ray image were provided to confirm the migration.The migrating/backing out cannot be replicated.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the concorde bullet migrating/backing out postoperatively cannot be determined from the sample and information provided.A potential root cause cannot be determined since the report of the concorde bullet migrating/backing out could not be confirmed or replicated.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.

• Brand Name: TI CONC BULLET LORD 9X9X27
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8363273
• Report Number: 1526439-2019-51378
• Device Sequence Number: 11271515
• Product Code: MQP
• UDI-Device Identifier: 10705034454412
• UDI-Public: (01)10705034454412
• Combination Product (Y/N): N
• PMA/510(K) Number: K151352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 196927519
• Device Catalogue Number: 196927519
• Device Lot Number: 511996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 03/14/2019; 04/19/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 04/05/2019; 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention