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

Model Number	0130
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was cancelled.
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.**correction: the correct fda registration number is (b)(4).
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: missing balloon.Probable root cause: design: inadequate raw material selection; poor assembly design; inadequate packaging design.Process: incorrect raw materials used during processing; device incorrectly assembled.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text: 81.
Event or Problem Description
It was reported that the procedure was cancelled.

• Brand Name: INSPACE? US SMALL
• Common Device Name: SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL
• Manufacturer (Section D): ORTHOSPACE LTD.; 7 halamish st.; caesarea CA 30795 79; IS 3079579
• Manufacturer (Section G): ORTHOSPACE LTD.; 7 halamish st.; caesarea 30795 79; IS 3079579
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16590693
• Report Number: 3016573902-2022-00004
• Device Sequence Number: 14686852
• Product Code: QPQ
• UDI-Device Identifier: 17290013396041
• UDI-Public: 17290013396041
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: DEN200039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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: 0130
• Device Catalogue Number: 0130
• Device Lot Number: 30052207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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