MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-26 for BIOINDUCTIVE IMPLANT - MEDIUM 2169-2 manufactured by Rotation Medical.
[146373148]
Investigation narrative: preliminary investigation including a review of the device history record did not reveal any manufacturing or production issues and the device was confirmed to be sterile. The physician apparently used an extreme angle when trying to remove the delivery instrument and cartridge after deploying the bioinductive implant. This resulted in the cartridge head component (nitinol fingers and cartridge sheath) being left in the patient's fatty tissue. The rep stated that the physician admitted later that it was poor technique and possibly user error. The patient was described as morbidly obese, which may have contributed to the physician not being aware he left part of the device behind. Fluoroscopy upon completion of procedure on (b)(6) 2019 confirmed no further retained foreign body and no further complications have been reported. If additional information is received, the investigation will be revisited. There is no indication that the device did not meet product specifications upon release into distribution.
Patient Sequence No: 1, Text Type: N, H10
[146373149]
Patient underwent arthroscopic repair of glutea tendon with a regeneten patch (bio-inductive collagen implant). Patch successfully placed, anchored and deployment instrument removed. Surgical procedure completed and patient discharged to home the same day. Patient returned for two week follow-up with orthopedist at which time imaging was completed and showed a retained foreign body suspected to be in subcutaneous tissue or it band. The patient returned to or on (b)(6) 2019, the foreign body location was confirmed with fluoroscopy and the piece was retrieved. The removed foreign body was identified as the spring mechanism of the delivery system for the regeneten patch and a small plastic piece attached to it. Fluoroscopy confirmed no further retained foreign body. The patient was discharged to home on the same day. No further complications have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009351468-2019-00005 |
| MDR Report Key | 8558480 |
| Date Received | 2019-04-26 |
| Date of Report | 2019-03-29 |
| Date of Event | 2019-02-16 |
| Date Mfgr Received | 2019-03-29 |
| Date Added to Maude | 2019-04-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GARRETT AHLBORG |
| Manufacturer Street | 15350 25TH AVENUE NORTH SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7637467531 |
| Manufacturer G1 | ROTATION MEDICAL |
| Manufacturer Street | 15350 25TH AVENUE NORTH SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIOINDUCTIVE IMPLANT - MEDIUM |
| Generic Name | MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON |
| Product Code | OWY |
| Date Received | 2019-04-26 |
| Catalog Number | 2169-2 |
| Lot Number | RC2AN18K4 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROTATION MEDICAL |
| Manufacturer Address | 15350 25TH AVENUE NORTH SUITE 100 PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-26 |