MAUDE Adverse Event Report: STRYKER GMBH CROSS PLATE MTP, LEFT ANCHORAGE; PLATE, FIXATION, BONE

Catalog Number	PLP14341
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported that the patient presented with pain in her foot, which she had for 6 months following initial implantation with an anchorage plate.The patient also reported that part of the toe did not flex.The patient had 2 opinions post operatively when she presented with the pain plus x-rays and scans which showed no issue with the plate.During a 3rd consultation, a spectoral scan showed pressure in areas over 4 of the 5 screws.The plate was revised.
Additional Manufacturer Narrative
Corrections to concomitant medical products and device evaluated by mfr.The reported event that cross plate mtp, left anchorage was alleged of 'additional/revision procedure' due to pain could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported that the patient presented with pain in her foot, which she had for 6 months following initial implantation with an anchorage plate.The patient also reported that part of the toe did not flex.The patient had 2 opinions post operatively when she presented with the pain plus x-rays and scans which showed no issue with the plate.During a 3rd consultation, a spectoral scan showed pressure in areas over 4 of the 5 screws.The plate was revised.

• Brand Name: CROSS PLATE MTP, LEFT ANCHORAGE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7700736
• Report Number: 0008031020-2018-00513
• Device Sequence Number: 1065630
• Product Code: HRS
• UDI-Device Identifier: 07613252260554
• UDI-Public: 07613252260554
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K083447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: PLP14341
• Device Lot Number: F37444
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention