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

Catalog Number	6190080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.
Event or Problem Description
Pre-operative diagnosis for this procedure: cervical fusion type of procedure or technique used: acdf(anterior cervical discectomy and fusion) levels implanted: 4 it was reported that during surgery, bottom of the plate broke off when surgeon was screwing the bottom portion.Plate was removed and retained.No fragment of the product remained in the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual examination confirms implant assembly separated.Optical and microscopic examination of the implant reveals ratchet spring pocket is cracked and deformed open.Microscopic examination reveals implant end component ratcheting catch features and ratchet spring pocket plastically deformed, consistent with intraoperative tensile overload.Bone screw witness marks noted at the base of the on separated component screw holes.Additionally, plate separation occurred intraoperatively during screw placement, testing determined that hyper angulated or off-center screw insertion could result in loads capable of disassembling the plates.This observation, in conjunction with the aforementioned plastic deformation of the mating ratcheting components is consistent with hyper angulated and/or off-center screw insertion resulting in the aforementioned plate disassembly.Conclusion: the above observations are consistent with hyper angulated and/or off-centered screw insertion, resulting in tensile overload of implant assembly.
Additional Manufacturer Narrative
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: 6492878
• Report Number: 1030489-2017-00894
• Device Sequence Number: 1626856
• Product Code: KWQ
• UDI-Device Identifier: 00613994235763
• UDI-Public: 00613994235763
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6190080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: Not provided; 05/10/2017
• Initial Report FDA Received Date: 04/14/2017
• Supplement Report FDA Received Date: 05/30/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR