MAUDE Adverse Event Report: SEASPINE INC. CAMBRIA NM; IMPLANT, FIXATION DEVICE, SPINAL

Model Number 39-2609-S

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2019 seaspine was made aware of a revision surgery had taken place to remove a non-fused implant.It was noted an additional complaint was made against a competitor alleging a cracked cervical plate and screw at levels c4-c5.Revision surgery was completed with no harm to the patient.Surgeon will monitor patient.During the review of the dhr for lot au19547605d, it was concluded that the product was inspected and accepted for use by the quality control department on (b)(6) 2017 and met all specified parameters of the receiving inspection report with no associated nonconformance specific to the product issue in the past 24 months from the awareness date ((b)(6) 2019), this is the first complaint received for non-union (.04%; based on 2,800 cambria nm implant cases).The occurrence for this event type is identified as remote (0.01-0.5%).Trend review for the fault type does not indicate an adverse trend exists at this time.No noted failure of cambria nm implant.The implant meets specifications and a dhr review concluded the implant met all specified parameters of the receiving inspection report with no associated nonconformance specific to the product issue.Review of labeling notes: possible adverse events: bending, disassembly or fracture of implant and components.Loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.Postoperative warnings the patient should be advised that implants may bend, break or loosen despite restriction in activity.Unable to determine root cause of implant and non-union.The anatomical condition of the patient may have played a role in non-fusion with implant.All testing and evaluation of returned product concludes the device was made to specification both in material composition and dimensionally.

Event Description

Index surgery (b)(6) 2018; multi-level acdf c4-c7.Revision to remove implant performed (b)(6) 2019 due to c4/c5 non-union implant and removal of a (competitor) broken anterior plate and screw.

• Brand Name: CAMBRIA NM
• Type of Device: IMPLANT, FIXATION DEVICE, SPINAL
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; calsbad CA 92008
• Manufacturer Contact: aaron ; 5770 armada drive
• MDR Report Key: 8501607
• MDR Text Key: 151917864
• Report Number: 3012120772-2019-00011
• Device Sequence Number: 1
• Product Code: JDN
• UDI-Device Identifier: 00889981064948
• UDI-Public: 00889981064948
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 39-2609-S
• Device Lot Number: AU19547605D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR