MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN UNKNOWN_FRO_PRODUCT; IMPLANT

Catalog Number UNK_FRO

Device Problem Positioning Problem (3009)

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

Event Date 01/01/2007

Event Type  malfunction  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.After several attempts, we have insufficient information to determine if the implant is available for return.

Event Description

It was reported that an additional surgery was required due to the medpor titan implant posterior resting.

Manufacturer Narrative

Although the complained implant has not been returned, the reported event could be confirmed, because a picture that shows the failure was provided.The complained event has been discussed with the related r&d department, which got in contact with 2 surgeons of the related paper.The following was provided by the r&d department: this appears to be a case where the surgeon did not place the implant correctly, or bent it too much before placement so that the posterior edge was too high, or possibly that the implant moved or ¿rocked¿, (displaced slightly inferiorly on the anterior edge so that the posterior edge moved superiorly) after it was placed.Based on the statistical evaluation no indications for any design, material or manufacturing related problems were found in this investigation.Therefore no corrective and/or preventive actions are deemed necessary at this time.

Event Description

It was reported that an additional suregery was required due to the medpor titan implant posterior resting.

• Brand Name: UNKNOWN_FRO_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer (Section G): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer Contact: hans geiger ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 5689386
• MDR Text Key: 47332457
• Report Number: 0008010177-2016-00113
• 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: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 05/04/2016
• 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