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

Catalog Number 0128

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2022

Event Type  Injury  

Event Description

It was reported that the procedure was cancelled and a new procedure was required.

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).

Manufacturer Narrative

Device investigation conclusions: based on the event description by the user, communication log, visual inspection and functional testing of the returned device, it can be concluded that: the device dhr is complete.The device lot was released for commercial and clinical use according to specifications.The handle mechanism works according to specifications.The nature of the inspace production process consists of manual folding process of each unit followed by protecting sheath assembly.Since the balloon is folded inside the protecting sheath it is necessarily that product is packed in the next step (blister sealing) with a balloon.It is not possible that a product was manufactured without a folded balloon.Possible scenario, based on the red safety button that was found opened, is that during the surgical procedure, premature plugging and/or disconnection of the balloon from the tube tip could occur by accidental premature rotation of the green knob during the device positioning, before moving the protecting sheath backwards and exposing the balloon.In the event that further information 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.Therefore: the exact root cause cannot be determined.Manufacture date is not known.Correction: the correct fda registration number is 3016573902.

Event Description

It was reported that the procedure was cancelled and a new procedure was required.

• Brand Name: INSPACE IMPLANT - MEDIUM
• Type of Device: 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16591960
• MDR Text Key: 311775044
• Report Number: 3016573902-2022-00007
• Device Sequence Number: 1
• Product Code: QPQ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: DEN200039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

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: 0128
• Device Lot Number: 090322-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 10/06/2022
• Supplement Dates FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 70 KG