MAUDE Adverse Event Report: SIGNUS MEDIZINTECHNIK GMBH NUBIC; NUBIC PEEK CERVICAL CAGE 7X13X17MM

Model Number	NUBIC
Medical Device Problem Codes	Nonstandard Device (1420); Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer complaint has revealed that the following product ref: nb071317 description: nubic peek cervical cage 7x13x17mm lot: 816889-av contains a wrong product.This wrong product is not intended for treatment of the cervical spinal column and is not compatible with the nubic surgical instruments.Our investigations revealed that a product mix-up occurred during the packaging process.Only the product and lot number mentioned above are affected.The product and lot number affected was distributed in (b)(6) only.There is no action required outside germany.There is a potential risk that in a particular case the necessary implant might not be available for surgical treatment.(b)(4).
Event or Problem Description
A customer complaint has revealed that the following product ref: nb071317, nubic peek cervical cage 7x13x17mm, lot 816889-av contains a wrong product.This wrong product is not intended for treatment of the cervical spinal column and is not compatible with the nubic surgical instruments.

• Brand Name: NUBIC
• Common Device Name: NUBIC PEEK CERVICAL CAGE 7X13X17MM
• Manufacturer (Section D): SIGNUS MEDIZINTECHNIK GMBH; industriestrasse 2; alzenau, 63755 ; GM 63755
• MDR Report Key: 9189985
• Report Number: 9615021-2019-00005
• Device Sequence Number: 2866163
• Product Code: ODP
• UDI-Device Identifier: 04047844010563
• UDI-Public: 04047844010563
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/14/2019

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: 04/30/2024
• Device Model Number: NUBIC
• Device Catalogue Number: NB071317
• Device Lot Number: 816889-AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1