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

Catalog Number	78-70020
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
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 the implant was larger than expected and did not match the pre op scan.The surgeon modified the implant to fit.There were no adverse events reported.
Event or Problem Description
It was reported the implant was larger than expected and did not match the pre op scan.The surgeon modified the implant to fit.There were no adverse events reported.
Additional Manufacturer Narrative
A complaint analysis was performed by stryker¿s custom design team.The implant was correctly designed and the implant was created with the requested features to fit the patient's defect.The patient scan was taken on (b)(6) 2023 and the implant was designed on (b)(6) 2023.The implant was delivered on (b)(6) 2023.The manufacturing analysis showed no deviations.However, it was noted on page 3 of the design proposal that there were calcification and free-floating bone fragments present in the temporal area as well as superiorly of the defect.It was recommended that these fragments and calcifications be removed before device implantation to assure an optimal fit.The surgeon may have been not aware that the design had a pterional plus feature.Thus, the implant was not designed to the defect rim in the temporal region.In conclusion, the peek was designed according and manufactured according to specification.H3 other text : implanted.

• Brand Name: PEEK CUSTOMIZED-PLUS-M
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 18042317
• Report Number: 0008010177-2023-00069
• Device Sequence Number: 7465826
• Product Code: GWO
• UDI-Device Identifier: 07613327300017
• UDI-Public: 07613327300017
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K152076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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: 78-70020
• Device Lot Number: 2309151017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown