MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2002-02-28 for UNK manufactured by Linvatec Corp..
[263766]
Allegation received that a bioabsorbable fixation was used to repair a rotator cuff tear. The procedure was completed with no reported complications. Several months later the patient returned to be evaluated for a clicking noise in the shoulder. The operative site was re-explored and it was noted that the bioabsorbable device had broken. The device was removed and the patient needed no further surgical intervention. Unable to verify product or patient data as no information was received from user facility or physician. The device was not returned or any information received to identify the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2002-00018 |
| MDR Report Key | 379533 |
| Report Source | 00 |
| Date Received | 2002-02-28 |
| Date of Report | 2002-02-06 |
| Date of Event | 2000-07-11 |
| Date Mfgr Received | 2002-02-06 |
| Date Added to Maude | 2002-03-06 |
| 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 | 0 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ROGER MURPHY |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33733 |
| Manufacturer Country | US |
| Manufacturer Postal | 33733 |
| Manufacturer Phone | 7273995205 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | BIOABSORBABLE SCREW |
| Product Code | MBJ |
| Date Received | 2002-02-28 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 368563 |
| Manufacturer | LINVATEC CORP. |
| Manufacturer Address | 11311 CONCEPT BLVD. LARGO FL 33733 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-02-28 |