MAUDE Adverse Event Report: WARSAW ORTHOPEDICS ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	6190045
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-op diagnosis: herniated disc it was reported that the patient underwent anterior cervical discectomy and fusion due to herniated disc.Post-op, the plate appeared damaged at the parts which link together and it separated in the patient.Hence, a revision surgery was performed on (b)(6) 2017 for removal of plate, a new plate was put in.No patient complications were reported as a result of this revision surgery.
Additional Manufacturer Narrative
X-ray review: post-op x-ray for two level acdf (anterior cervical discectomy and fusion) show dislocation of translational plate.No intra-op or immediate post-op x-rays are available and hence, the root cause was indeterminate.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Visual review of the returned implant confirmed the implant was dis-assembled at the joint between the intermediate component ratchet pocket and the end component ratchet catch features.The ratchet spring component was missing as-received and not returned for analysis.Visual and microscopic examination identified witness marks and material deformation within and around the male/male intermediate component ratchet pocket, verifying the presence of the ratchet spring during initial assembly.Witness marks and material deformation were identified on the end component ratchet catch features; this demonstrates the implant was initially properly assembled.Additionally, these witness marks and material deformation around the ratchet spring pocket were similar in location and morphology to those noted on tensile overload testing sample.Dimensional examination of ratchet spring pocket and associated features verified conformance to print specification.Gouging from ratchet interface feature deformation suggest possible escape point of ratchet spring.Multiple areas of significant damage and deformation.The above observations lead to the conclusion that the plate became disassembled due to tensile overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6776304
• Report Number: 1030489-2017-01884
• Device Sequence Number: 11147701
• Product Code: KWQ
• UDI-Device Identifier: 00613994235886
• UDI-Public: 00613994235886
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K063100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2017

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: Health Professional
• Device Catalogue Number: 6190045
• Device Lot Number: 0368196W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Initial Date Received by Manufacturer: 07/14/2017
• Supplement Date Received by Manufacturer: 08/15/2017; 10/16/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 09/11/2017; 11/09/2017
• 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
• Patient Age: 62 YR