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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ISOTIS ORTHOBIOLOGICS INC. SYNPLUG CEMENT RESTRICTOR; CEMENT OBTURATOR

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ISOTIS ORTHOBIOLOGICS INC. SYNPLUG CEMENT RESTRICTOR; CEMENT OBTURATOR Back to Search Results
Model Number 804020
Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Patient Problem Osteolysis (2377)
Event Date 07/31/2023
Event Type  malfunction  
Event Description
On (b)(6) 2023, seaspine received information regarding a patient who had previously undergone hip surgery involving the use of synplug.During a follow-up visit, radiography revealed the presence of osteolysis in the region where the synplug was implanted.
 
Manufacturer Narrative
The provided radiographs suggest that the biodegradable cement restrictor has undergone degradation.Existing literature indicates the possibility of additional deterioration in the hip prosthesis, potentially leading to a heightened risk of joint fracture.The prosthesis remains in place and no revision surgery has taken place.Osteolysis is evident, but it remains unclear whether this phenomenon is primarily caused by the device or if other physiological factors and interactions play a contributing role.Field safety corrective action (fsca-o-hhe-701) was undertaken to provide safety alert to physicians regarding the possible risk.At or around that time (2014), market withdrawal and destruction of unused product occurred.
 
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Brand Name
SYNPLUG CEMENT RESTRICTOR
Type of Device
CEMENT OBTURATOR
Manufacturer (Section D)
ISOTIS ORTHOBIOLOGICS INC.
2 goodyear, suite a
irvine CA 92618
Manufacturer (Section G)
ISOTIS ORTHOBIOLOGICS INC.
2 goodyear, suite a
irvine CA 92618
Manufacturer Contact
audrey mudderman
5770 armada dr.
carlsbad, CA 92008
MDR Report Key17862122
MDR Text Key325389686
Report Number3001503333-2023-00005
Device Sequence Number1
Product Code LZN
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K010840
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/03/2023
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 Health Professional
Device Model Number804020
Device Catalogue Number804020
Device Lot Number115.524/B
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/27/2023
Initial Date FDA Received10/03/2023
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 Number1
Patient Outcome(s) Other;
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