MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UNKNOWN_FRO_PRODUCT; IMPLANT

Catalog Number UNK_FRO

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/11/2017

Event Type  Injury  

Manufacturer Narrative

The device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device is implanted in patient.

Event Description

It was reported by a company representative that upon completion of a left orbital surgery the surgeon performed a revision surgery after determining an implant did not fit correctly from the initial surgery.During the revision surgery the implant was trimmed but not removed, and there was no infection or other problems reported.

Manufacturer Narrative

The reported event could not be confirmed, because the product was not returned for investigation and also no x-ray images were provided.No lot number was provided, so a review of the specific manufacturing batch record and related quality documents (manufacturing documents, inspection plan, inspection drawing and release report) could not be performed.Therefore, it is also not possible to determine the quantity released for distribution within the affected lot.The sales rep was contacted to provide further insights within this complaint.It was stated that the implant did fit after the surgeon softened the contour around the orbit.No x-ray images after initial surgery or prior to revision surgery are available to study the implant position within the defect.Apart from the information already included in the updated event description, no further information is known.The provided information was not sufficient to determine the root cause of this complaint.According to the related risk management file, possible causes for the hazard ¿poor fit of implant¿ could have been: hcp inexperienced with medpor implants.Insufficient intra-op planning tools.Incorrect selection of implant.Based on the investigation and the corresponding statistical evaluation, there is no indication for a "not correctly working product" or any 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.

Event Description

It was reported by a company representative that upon completion of a left orbital surgery the surgeon performed a revision surgery after determining an implant did not fit correctly from the initial surgery.During the revision surgery the implant was trimmed but not removed, and there was no infection or other problems reported.

• Brand Name: UNKNOWN_FRO_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer Contact: gregory gohl ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 6822331
• MDR Text Key: 83704028
• Report Number: 0008010177-2017-00216
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_FRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1