MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-LIMERICK UNKNOWN_FRO_PRODUCT; IMPLANT

Catalog Number UNK_FRO

Device Problem Crack (1135)

Patient Problems Cerebrospinal Fluid Leakage (1772); Inadequate Osseointegration (2646)

Event Date 03/24/2022

Event Type  Injury  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.

Event Description

It was reported by the company representative that a csf leak was noticed post op.A second surgery was performed and upon reoperation, surgeon noticed the direct inject had cracked.No further information is known at this time.

Manufacturer Narrative

The observation stated in the reported event could not be confirmed as the provided information, necessary for a detailed evaluation of the event, was not sufficient.Unfortunately, the catalog# and lot# of the directinject product could not be provided.However, it could be confirmed that the defect was closed in less than 10 minutes.Additionally, it could be confirmed that there was no pressure applied to the bone cement after it was implanted and it was mentioned that the re-operation was done to prevent the cerebrospinal fluid from leaking.The surgeon confirmed that this was not caused by directinject.No pictures of the cracked bone cement could be provided.Summarizing all obtained information, the root cause for this reported event could not be determined.H3 other text :device not available.

Event Description

It was reported by the company representative that a csf leak was noticed post op.A second surgery was performed and upon reoperation, surgeon noticed the direct inject had cracked.No further information is known at this time.

• Brand Name: UNKNOWN_FRO_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 76145120
• MDR Report Key: 14186640
• MDR Text Key: 289871989
• Report Number: 0008010177-2022-00014
• Device Sequence Number: 1
• Product Code: GXP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143661
• 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: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UNK_FRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2022
• 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
• Patient Outcome(s): Required Intervention