MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK CUSTOMIZED COMPLEX-PLUS-L; IMPLANT

Model Number	78-60030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
Event or Problem Description
It was reported by the company representative that the product was implanted and bleeding was noticed under the implant post operatively.There was a revision surgery completed to remove the implant.
Additional Manufacturer Narrative
Further information has been requested regarding the reported event.In a follow-up, sales rep has men-tioned that during visual inspection, ¿(¿) it did not show anything sharp or irregular prior to implantation.(¿)¿ no further information has been received as to the exact location of the bleeding (e.G.Dura mater) and if the patient has suffered any consequences due to the bleeding.It is also unknown if the implant has been re-implanted or replaced.Based on statistical evaluation there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.Therefore, no further corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.Device is not available for evaluation.
Event or Problem Description
It was reported by the company representative that the product was implanted and bleeding was noticed under the implant post operatively.There was a revision surgery completed to remove the implant.

• Brand Name: PEEK CUSTOMIZED COMPLEX-PLUS-L
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 9883632
• Report Number: 0008010177-2020-00018
• Device Sequence Number: 10948214
• Product Code: GWO
• UDI-Device Identifier: 07613327300062
• UDI-Public: 07613327300062
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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?: No
• Operator of Device: No Information
• Device Model Number: 78-60030
• Device Catalogue Number: 78-60030
• Device Lot Number: 2002071020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1