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

Model Number	0132
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an infection that required a wash out.
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.
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.The reported failure mode will be monitored for future reoccurrence.Alleged failure: patient had infection probable root cause: design wrong raw material or manufacturing agent selected in-process cleaning not effective at removing manufacturing residuals not enough strict controls placed on raw material source and purity process sterilization fault - including eto residuals contamination during manufacturing process; including endotoxins in-process cleaning not performed to spec application contamination of instruments patient reaction/allergy sensitivity or with active/latent infection use of contrast media use of more than one implant within the shoulder wrong patient selection manufacture date is not known.
Event or Problem Description
It was reported that the patient had an infection that required a wash out.
Event or Problem Description
It was reported that the patient had an infection that required a wash out.
Additional Manufacturer Narrative
Correction: the incorrect fda registration number was used during the initial report.The correct fda registration number is 3016573902.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: patient had infection probable root cause: design - wrong raw material or manufacturing agent selected - in-process cleaning not effective at removing manufacturing residuals - not enough strict controls placed on raw material source and purity process - sterilization fault - including eto residuals - contamination during manufacturing process; including endotoxins - in-process cleaning not performed to spec application - contamination of instruments - patient reaction/allergy sensitivity or with active/latent infection - use of contrast media - use of more than one implant within the shoulder - wrong patient selection product was not received in-house at orthospace-stryker endoscopy, and reportability decision was checked for consistency.

• Brand Name: INSPACE US LARGE
• 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 CA 30795 79; IS 3079579
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 14688862
• Report Number: 0002936485-2022-00324
• Device Sequence Number: 6777840
• Product Code: QPQ
• UDI-Device Identifier: 17290013396065
• UDI-Public: 17290013396065
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 02/07/2023

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: 0132
• Device Catalogue Number: 0132
• Device Lot Number: 291121-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 05/18/2022; 05/18/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 08/15/2022; 02/07/2023
• 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