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

Model Number	79-45905
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; IE NA
• MDR Report Key: 9375468
• Report Number: 0008010177-2019-00073
• Device Sequence Number: 16937762
• Product Code: GXP
• UDI-Device Identifier: 07613327123265
• UDI-Public: 07613327123265
• Combination Product (Y/N): N
• PMA/510(K) Number: K143661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: 79-45905
• Device Catalogue Number: 79-45905
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1