MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXPEDIUM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	187701015
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	10/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is available for evaluation.Investigation will be conducted.Follow up will be filed with investigation 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
On (b)(6) 2016, surgery for scoliosis was performed using the expedium system.The fixed area was t11 ¿ l4.Recently, surgeon confirmed through an x-ray that set screws (part#: unk) fixed at caudal end were loosened and that rods had moved in upper position, resulting in loss of the corrective force.The surgeon decided to conduct re-operation next week because such loosened set screws might contact the heart of the patient.He will use non-j&j replacements at the re-operation scheduled next week.
Additional Manufacturer Narrative
Visual examination of the returned device revealed minor signs of damage, consistent with operative usage.The set screw shows rod striations indicative of proper tightening.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.A definitive root cause for the loosening cannot be determined.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.

• Brand Name: EXPEDIUM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7050002
• Report Number: 1526439-2017-11018
• Device Sequence Number: 1571512
• Product Code: KWQ
• UDI-Device Identifier: 10705034138336
• UDI-Public: (01)10705034138336
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

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
• Operator of Device: Physician
• Device Model Number: 187701015
• Device Catalogue Number: 187701015
• Device Lot Number: 104454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 01/19/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention