MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE CARBON-FIBER COMPOSITE, PARALLEL, 0°, 9X10X23MM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 187823110

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 05/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The two (2) concorde bullet 9 x 10 x 23 parallel cages [product code: 1878-23-110] were not returned to the customer quality unit (cqu) for evaluation.As a result, an investigation will be based on a no sample device evaluation.Should more information and/or the device samples become available at a later date, this complaint file will be reopened and the samples will then receive a full evaluation.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.A trend analysis was conducted.No emerging trends were found requiring further actions.Without the returned of the device we are unable to confirm the reported issue or identify the root cause.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.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The reported products were used in the original surgery for both ¿spinal canal stenosis¿ and ¿l4-l5 separated spondylolisthesis¿, stabilizing l3-l5, on (b)(6) 2017.After the initial surgery, it was found that the reported two cages ¿conc bullet parallel 9 x 10 x 23 (187823110)¿ had become backed out toward the spinal canal.Current treatment status: since any neurological symptom hasn¿t appeared, further surgery is not planned.So the (b)(6) female patient has been under observation.

• Brand Name: CARBON-FIBER COMPOSITE, PARALLEL, 0°, 9X10X23MM
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6643178
• MDR Text Key: 77634921
• Report Number: 1526439-2017-10431
• Device Sequence Number: 1
• Product Code: MQP
• 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: 05/17/2017

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
• Device Operator: Physician
• Device Catalogue Number: 187823110
• Device Lot Number: ATNBB5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR