MAUDE Adverse Event Report: K2M, INC. AN INTERBODY CONVEX; SIZE 10X22X14 MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6101-2102814NC-G2
Medical Device Problem Codes	Packaging Problem (3007); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that a sterile cascadia an interbody was noted to be the wrong size as it was being prepared on the back table during surgery.Further investigation identified that the labelling on the package indicated the device was a 10 x 28 x 14 mm interbody (6101-2102814nc-g2) while the device inside the packaging was actually a 10 x 22 x 15 mm interbody (6101-2102215nc-g2).The direct part marking on the device correctly identified the dimensions; the discrepancy was with the labels on the exterior packaging and the inner tyvek seal.The case was successfully completed following a ten-minute delay and there were no adverse consequences to the patient.
Additional Manufacturer Narrative
Correction to d4 (gtin/udi).
Event or Problem Description
A company representative reported that a sterile cascadia an interbody was noted to be the wrong size as it was being prepared on the back table during surgery.Further investigation identified that the labelling on the package indicated the device was a 10 x 28 x 14 mm interbody (6101-2102814nc-g2) while the device inside the packaging was actually a 10 x 22 x 15 mm interbody (6101-2102215nc-g2).The direct part marking on the device correctly identified the dimensions; the discrepancy was with the labels on the exterior packaging and the inner tyvek seal.The case was successfully completed following a ten-minute delay and there were no adverse consequences to the patient.
Additional Manufacturer Narrative
An urgent medical device recall letter was sent on (b)(6) 2021 to the affected customers.The urgent medical device recall letter was sent to notify customers that the affected product has been voluntarily recalled by stryker and will be removed from their inventory by the local representative.
Event or Problem Description
A company representative reported that a sterile cascadia an interbody was noted to be the wrong size as it was being prepared on the back table during surgery.Further investigation identified that the labelling on the package indicated the device was a 10 x 28 x 14 mm interbody (6101-2102814nc-g2) while the device inside the packaging was actually a 10 x 22 x 15 mm interbody (6101-2102215nc-g2).The direct part marking on the device correctly identified the dimensions; the discrepancy was with the labels on the exterior packaging and the inner tyvek seal.The case was successfully completed following a ten-minute delay and there were no adverse consequences to the patient.
Additional Manufacturer Narrative
An urgent medical device recall letter was sent on (b)(6) 2021 to the affected customers.The urgent medical device recall letter was sent to notify customers that the affected product has been voluntarily recalled by stryker and will be removed from their inventory by the local representative.
Event or Problem Description
A company representative reported that a sterile cascadia an interbody was noted to be the wrong size as it was being prepared on the back table during surgery.Further investigation identified that the labelling on the package indicated the device was a 10 x 28 x 14 mm interbody (6101-2102814nc-g2) while the device inside the packaging was actually a 10 x 22 x 15 mm interbody (6101-2102215nc-g2).The direct part marking on the device correctly identified the dimensions; the discrepancy was with the labels on the exterior packaging and the inner tyvek seal.The case was successfully completed following a ten-minute delay and there were no adverse consequences to the patient.

• Brand Name: AN INTERBODY CONVEX; SIZE 10X22X14 MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11747102
• Report Number: 3004774118-2021-00130
• Device Sequence Number: 3856435
• Product Code: MAX
• UDI-Device Identifier: 10888857160613
• UDI-Public: 10888857160613
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K172009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/25/2021

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 Model Number: 6101-2102814NC-G2
• Device Catalogue Number: 6101-2102214NC-G2
• Device Lot Number: NCMR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 05/10/2021; 04/28/2021; 07/30/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 05/10/2021; 05/14/2021; 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 87905
• Patient Sequence Number: 1
• Patient Age: 53 YR