| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MERSILENE TAPE UNKNOWN PRODUCT | INSTRUMENT, SURGICAL, DISPOSABLE | ETHICON INC. | KDC | UNK | UNK | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-11-20 | 0 | 1. R |
Patient 1
(B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: ORTHOPEDICS JUNE 2011 - VOLUME 34, ISSUE 6: E172-E177; DOI: 10.3928/01477447-20110427-10. (B)(4).
Patient 1
IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "TREATMENT OF ACUTE UNSTABLE DISTAL CLAVICLE FRACTURES WITH SINGLE CORACOCLAVICULAR SUTURE FIXATION." AUTHORS: SHAN-WEI YANG, MD; LI CHUN LIN, MD; SHWU JEN CHANG, PHD; SHWU JEN CHANG, MD; SHYH MING KUO, PHD; LAIN-CHYR HWANG, PHD. CITATION: ORTHOPEDICS JUNE 2011 - VOLUME 34, ISSUE 6: E172-E177; DOI: 10.3928/01477447-20110427-10. THIS PROSPECTIVE STUDY AIMED TO PRESENT IF SIMPLE METHOD OF SINGLE "CORACLAVICULAR" SUTURE FIXATION WITH MERSILENE TAPE WOULD MAINTAIN THE REDUCTION OF THE FRACTURE, RESTORE THE CORACLAVICULAR SPACE, AND PROVIDE ENOUGH STRENGTH TO KEEP REDUCTION UNTIL UNION OF THE FRACTURED SITE. FROM 2004 TO 2006, 28 PATIENTS (N=28 MALE AND N=10 FEMALE; MEAN AGE OF 37.9 YEARS [RANGED 19-71 YEARS]) WITH ACUTE, CLOSED NEER TYPE IIB DISTAL CLAVICULAR FRACTURES WERE TREATED WITH SINGLE CORACLAVICULAR SUTURE FIXATION USING MERSILENE TAPE. IN THE PROCEDURE, THE MERSILENE TAPE WAS PASS THROUGH THE INFERIOR BASE OF THE CORACOID PROCESS AND AROUND THE MEDIAL CLAVICULAR SEGMENT. POSTOPERATIVELY, ONE PATIENT EXPERIENCED FROZEN SHOULDER (WITH PAIN) ON THE TREATED SIDE WHICH RESOLVED AFTER ADEQUATE REHABILITATION, AND ANOTHER PATIENT REPORTED UNCOMFORTABLE SKIN TENTING DUE TO SUBCUTANEOUS PROTRUSION OF THE SUTURE NODE OF THE MERSILENE TAPE WHICH RESOLVED WITH SIMPLE SURGICAL REMOVAL OF THE NODE USING LOCAL ANESTHESIA AFTER BONY UNION OF THE FRACTURE SITE. SINGLE CORACOCLAVICULAR FIXATION WITH MERSILENE TAPE WAS EFFECTIVE IN ALL PATIENTS WITH ACUTE NEER TYPE IIB DISTAL CLAVICULAR FRACTURES WITHOUT ANY HARDWARE, EVEN IN PATIENTS WITH COMMINUTED DISTAL FRAGMENTS OR OSTEOPOROSIS. MERSILENE TAPE MAINTAINED THE REDUCTION OF THE FRACTURE AND RESTORED THE CORACOCLAVICULAR SPACE, AND IT CHANGED THE PATTERN OF THE FRACTURE FROM NEER TYPE II TO TYPE I.