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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOSPACE LTD. INSPACE US LARGE; SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL

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ORTHOSPACE LTD. INSPACE US LARGE; SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL Back to Search Results
Catalog Number 0132
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Swelling/ Edema (4577)
Event Date 08/29/2022
Event Type  Injury  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
 
Event Description
It was report that there was patient pain and swelling.
 
Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: pain probable root cause: design - inadequate raw material specification process - spacer not manufactured to specification - incorrect material used during manufacture - incorrect packaging or error in packaging process causes exposure to humidity or high temperatures application - use of expired product - wrong storage conditions (high temperatures or exposure to humidity <40%) - re-use of single-use device - use of contrast media - wrong patient or device selection - patient not following rehab procedure the reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.
 
Event Description
It was report that there was patient pain and swelling.
 
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Brand Name
INSPACE US LARGE
Type of Device
SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL
Manufacturer (Section D)
ORTHOSPACE LTD.
7 halamish st.
caesarea 30795 79
IS  3079579
Manufacturer (Section G)
ORTHOSPACE LTD.
7 halamish st.
caesarea 30795 79
IS   3079579
Manufacturer Contact
lucas wolski
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key16696535
MDR Text Key312857784
Report Number3016573902-2023-00001
Device Sequence Number1
Product Code QPQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
DEN200039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/24/2024
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
Device Operator Health Professional
Device Catalogue Number0132
Device Lot Number230322-06
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/10/2023
Initial Date FDA Received04/06/2023
Supplement Dates Manufacturer Received03/10/2023
Supplement Dates FDA Received01/24/2024
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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