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

Catalog Number UNK_ENO

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Inflammation (1932); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/30/2019

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.The catalog number is not known at this time, therefore the gtin could not be determined.However, should it become available it will be provided in future reports.**correction: the incorrect fda registration number was used during the initial report.The correct fda registration number is (b)(4).

Event Description

It was reported that there was an infection that required a wash out.

Manufacturer Narrative

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: inflammatory reaction.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 (i.E.Residues and leachable dcm, ethanol and acetone).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.H3 other text : 81.

Event Description

It was reported that there was an infection that required a wash out.

• Brand Name: UNKNOWN_ORTHOSPACE_PRODUCT
• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16590694
• MDR Text Key: 311760680
• Report Number: 3016573902-2022-00002
• Device Sequence Number: 1
• Product Code: QPQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN200039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_ENO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 06/24/2022
• Supplement Dates FDA Received: 06/02/2023
• 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 Number: 1
• Patient Outcome(s): Other