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

Catalog Number	0131
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the patient had a subcutaneous development of ¿cottage cheese¿ type consistency.
Event or Problem Description
It was reported that the patient had a subcutaneous development of ¿cottage cheese¿ type consistency.
Additional 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: patient complication probable root cause: 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, 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.The manufacturing date is unknown.
Additional Manufacturer Narrative
Correcting probable root causes listed below as per quality engineer review these are the most applicable: 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: patient complication probable root cause: application use of expired product wrong storage conditions 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.The manufacturing date is unknown.
Event or Problem Description
It was reported that the patient had a subcutaneous development of ¿cottage cheese¿ type consistency.
Event or Problem Description
It was reported that the patient had a subcutaneous development of ¿cottage cheese¿ type consistency.
Additional Manufacturer Narrative
Per additional review, the below is the updated investigation conclusion.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: patient complication probable root cause: application - patient reaction/allergy sensitivity with or - surgical procedure introduces active/latent infection - wrong patient selection - general reaction to procedure the reported failure mode will be monitored for future reoccurrence.Stryker will continue to monitor for any reports or trends.

• Brand Name: INSPACE US MEDIUM
• Common Device Name: SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATAB
• Manufacturer (Section D): ORTHOSPACE LTD.; 7 halamish st.; caesarea CA 30795 79; IS 3079579
• Manufacturer (Section G): ORTHOSPACE LTD.; 7 halamish st.; caesarea CA 30795 79; IS 3079579
• Manufacturer Contact: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 19486602
• Report Number: 3016573902-2024-00005
• Device Sequence Number: 15434908
• Product Code: QPQ
• UDI-Device Identifier: 17290013396058
• UDI-Public: 17290013396058
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: DEN200039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/25/2025

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 Catalogue Number: 0131
• Device Lot Number: 091123-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 05/13/2024; 05/13/2024; 06/30/2025
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 09/19/2024; 09/23/2024; 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown