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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-LIMERICK DIRECTINJECT ON DEMAND HA CEMENT; IMPLANT
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STRYKER ORTHOPAEDICS-LIMERICK DIRECTINJECT ON DEMAND HA CEMENT; IMPLANT Back to Search Results
Model Number 79-45903
Device Problem Material Erosion (1214)
Patient Problems Impaired Healing (2378); Inadequate Osseointegration (2646)
Event Date 07/11/2020
Event Type  Injury  
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 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.
 
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 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.
 
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Brand Name
DIRECTINJECT ON DEMAND HA CEMENT
Type of Device
IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-LIMERICK
raheen business park
limerick NA
EI  NA
MDR Report Key10793120
MDR Text Key214821292
Report Number0008010177-2020-00056
Device Sequence Number1
Product Code FWP
UDI-Device Identifier07613327123371
UDI-Public07613327123371
Combination Product (y/n)N
PMA/PMN Number
K952677
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number79-45903
Device Catalogue Number79-45903
Was Device Available for Evaluation? No
Date Manufacturer Received10/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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