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

Model Number	39-2609-S
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: IMPLANT, FIXATION DEVICE, SPINAL
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; calsbad CA 92008
• MDR Report Key: 8501607
• Report Number: 3012120772-2019-00011
• Device Sequence Number: 14152636
• Product Code: JDN
• UDI-Device Identifier: 00889981064948
• UDI-Public: 00889981064948
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K171046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2019

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?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR