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

Model Number	79-45903
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Impaired Healing (2378); Inadequate Osseointegration (2646)
Date of Event	07/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device is not available for evaluation.
Event or Problem Description
It was reported that a patient underwent a posterior cranial craniotomy during acoustic schwannoma removal surgery.A couple weeks later, lumbar spine drainage was performed because cerebrospinal fluid leakage was confirmed from the postoperative wound.The lumbar drainage eliminated the csf leakage, but the bone cement had solidified inside the scalp wound, hindering spontaneous healing.As a result, a follow up surgery was performed to remove the subcutaneous cement and treat wounds.
Additional Manufacturer Narrative
The observation stated in the reported event could not be confirmed as the provided details, necessary for a detailed evaluation of the event, were not sufficient.For additional information on the complained event it was reached out to the related raqa team to gather information about complaint.It was stated that the customer cannot recall how thick the bone cement was applied in the defect area.Furthermore, it could not be traced how big the defect size filled up with the bone cement was.Additionally, there was no information available about a possible pulsation of the dura/brain due to the reporting hp policy.Due to the hp policy the lot number of the product could not be provided.Furthermore, the manufacturing site stryker limerick did not perform a testing of two retain samples since lot number of the product could not be provided.The r&d team of the manufacturing site of stryker limerick was contacted to assess the request of the surgeon.It was stated that the cement was most likely applied thinly to the margin of the defect then it could have been broken and dislodged by the pressure from the csf leak and transported to the skin wound.The cement particles are not soluble to such an extent that it would be noticeable.Hydroxyapatite has a solubility of ~0.009g/l at physiological ph which would not be noticeable, cement is therefore remodeled through osteoclast/osteoblast activity to new bone over time.Therefore, the most likely root cause of this complaint is a postoperative breakage of the cement.This answer to the surgeons¿ request was also passed to the raqa team in japan to share the information.H3 other text : device is not available for return.
Event or Problem Description
It was reported that a patient underwent a posterior cranial craniotomy during acoustic schwannoma removal surgery.A couple weeks later, lumbar spine drainage was performed because cerebrospinal fluid leakage was confirmed from the postoperative wound.The lumbar drainage eliminated the csf leakage, but the bone cement had solidified inside the scalp wound, hindering spontaneous healing.As a result, a follow up surgery was performed to remove the subcutaneous cement and treat wounds.

• Brand Name: DIRECTINJECT ON DEMAND HA CEMENT
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• MDR Report Key: 10793120
• Report Number: 0008010177-2020-00056
• Device Sequence Number: 2988441
• Product Code: FWP
• UDI-Device Identifier: 07613327123371
• UDI-Public: 07613327123371
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K952677
• 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): 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 79-45903
• Device Catalogue Number: 79-45903
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention