MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-LIMERICK DIRECTINJECT ON DEMAND HA CEMENT; IMPLANT

Model Number 79-45905

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2019

Event Type  malfunction  

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 that during a reoperative procedure for a csf leakage, that the 3cm diameter size paste injected with direct inject was broken a part.

Manufacturer Narrative

The reported event could not be confirmed, because the information provided was not sufficient.To gain more information about the complained event the sales rep was contacted.No additional information regarding the complaint could be provided.No lot number was provided, thus a review of the specific manufacturing batch records and related quality documents (manufacturing documents, inspection plan, inspection drawing and release report) cannot be performed.Therefore, it is also not possible to determine the quantity released for distribution within the affected lots.Based on the investigation including the labeling review as well as the event description it can be confirmed that the surface area of the cranial defect was too large.In the event description it was stated that the circular defect of the occipital bone had a diameter of 3 cm.This results in a surface area of over 7 cm² which contradicts to the recommended maximum surface area of 4 cm² in the corresponding ifu.With such a large defect in the occipital bone a loss of the cements mechanical stability due to a breakage is a likely result.Thus, the complaint is declared as noncompliant usage.Therefore, no corrective and/or preventive actions are deemed necessary at that time.However, post market surveillance will continue to monitor complaints of this type.The complaint is added to the complaint trend.

Event Description

It was reported that during a re operative procedure for a csf leakage, that the 3cm diameter size paste injected with directinject was broken a part.

• Brand Name: DIRECTINJECT ON DEMAND HA CEMENT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; IE NA
• MDR Report Key: 9375468
• MDR Text Key: 175197644
• Report Number: 0008010177-2019-00073
• Device Sequence Number: 1
• Product Code: GXP
• UDI-Device Identifier: 07613327123265
• UDI-Public: 07613327123265
• Combination Product (y/n): N
• PMA/PMN Number: K143661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 79-45905
• Device Catalogue Number: 79-45905
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 11/11/2019
• Supplement Dates FDA Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1