MAUDE Adverse Event Report: SIGNUS MEDIZINTECHNIK GMBH RABEA; RABEA PEEK CERVICAL CAGE

Model Number	RABEA
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer complaint has revealed that the following medical device: ref: wk041214; rabea peek cervical cage angled 4x12x14mm 5°, lot 818192-kt - contains item pk041214, rabea peek - cervical cage parallel 4x12x14mm 0°.Our first investigations revealed that a wrong labelling occurred in the framework of the manufacturing process.Only the product mentioned above and only that single lot number is affected.It has not been definitively determined how many products are affected by the wrong labelling.There is a risk that patients who were treated with that product received a parallel cervical cage with a lordotic angle of 0° instead of 5°.There is no additional health risk for patients who had a parallel cage implanted instead of a lordotic cage.The position of the cage in relation to the adjacent vertebral bodies is being checked during the surgery.Based on that the surgeon decides whether the treatment is completed or whether there is a necessity for additional measures, e.G.A stabilization with a plate.Compared to the lordotic rabea cage the parallel cage is approx.1,2 mm higher on the posterior side.Therefore in comparison with the lordotic cage no additional strain on the neuronal structures is to be expected, all the more because the distraction of the vertebral bodies required for the surgical process is reversed after the implantation of the cage.A negative effect on the bony fusion starting after the surgery is not to be expected.In consideration of the risk assessment and the fact that no negative effects on the health of the patients involved are to be expected no additional aftercare measures are required.Signus doesn't deem it necessary to inform the patients about the situation.It is at the treating doctor's discretion to inform the patient if necessary.Affected devices have been distributed in (b)(6) only.
Event or Problem Description
A customer complaint has revealed that the following medical device: ref: wk041214; rabea peek cervical cage angled 4x12x14mm 5°, lot 818192-kt - contains item pk041214, rabea peek - cervical cage parallel 4x12x14mm 0°.Our first investigations revealed that a wrong labelling occurred in the framework of the manufacturing process.Only the product mentioned above and only that single lot number is affected.The device in question was not delivered to u.S.Market.

• Brand Name: RABEA
• Common Device Name: RABEA PEEK CERVICAL CAGE
• Manufacturer (Section D): SIGNUS MEDIZINTECHNIK GMBH; industriestrasse 2; alzenau, bavaria 63755 ; GM 63755
• MDR Report Key: 10661105
• Report Number: 9615021-2020-00008
• Device Sequence Number: 3058408
• Product Code: OVE
• UDI-Device Identifier: 04047844000151
• UDI-Public: 04047844000151
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Replace,Notification
• Type of Report: Initial
• Report Date (Section B): 10/12/2020

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 Expiration Date: 05/31/2024
• Device Model Number: RABEA
• Device Catalogue Number: WK041214
• Device Lot Number: 818192-KT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1