MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG PEEK CUSTOMIZED CRANIAL IMPLANT, L

Model Number	78-40030
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Cerebral Edema (4403); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the surgery, it was noticed the peek implant was too small and not curved as expected.An alternative implant was used.A revision surgery was successfully performed to implant a new peek implant.
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported that during the surgery, it was noticed the peek implant was too small and not curved as expected.An alternative implant was used.A revision surgery was successfully performed to implant a new peek implant.
Additional Manufacturer Narrative
The reported event could be confirmed as an intraoperative image was provided.It was reported that the shape of the implant was too small and not curved enough.This was noticed when the patient was already under anesthesia and the defect exposed.Preliminary feedback was given on 23-mar-2022 to the sales representative, that the implant was designed per standard procedure with a shape that is symmetrical to the patient¿s contralateral side.It is possible to adjust the curvature of the implant to an e.G.More convex or concave shape, but this must be noted upon the order of the implant or must be discussed in a live design session with the surgeon.No further information was provided at that time, but information on the possibility re-sterilization was requested by the hospital.The hospital was informed that the peek device may be re-sterilized per the applicable instructions for use, but the device is intended for ¿1 use, or for use on a single patient during a single procedure.¿ the patient was revised on (b)(6) 2022, and the peek implant was reported having been ¿a perfect fit¿.In a follow-up meeting of the sales rep and the surgeon on (b)(6) 2022, the surgeon stated that swelling was still existent and not reduced during the first surgery, which caused the implant to not fit.Swelling was further pointed out on p.5 of the design proposal for this case.In conclusion, the implant was designed as requested by the customer.The root cause can be attributed to the patient condition and the swelling that was still present during surgery.Overall, the implant was designed according to all quality instructions, and manufactured to specification.H3 other text : device not available.

• Brand Name: PEEK CUSTOMIZED CRANIAL IMPLANT, L
• 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 ; 76145120
• MDR Report Key: 13971162
• Report Number: 0008010177-2022-00010
• Device Sequence Number: 6626804
• Product Code: GWO
• UDI-Device Identifier: 07613327129298
• UDI-Public: 07613327129298
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K152076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 78-40030
• Device Catalogue Number: 78-40030
• Device Lot Number: 2201141008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown